Clinical Trial Results:
A Phase IIb/III, multi-centre, double-blind, randomised, placebo-controlled, dose ranging study of tamsulosin hydrochloride (low, medium and high dose) as treatment in children with neuropathic bladder for three months
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
Summary
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EudraCT number |
2006-003048-52 |
Trial protocol |
DE BE ES IT |
Global end of trial date |
12 Feb 2009
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Jul 2016
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First version publication date |
09 Aug 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
527.51
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00796614 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Boehringer Ingelheim
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Sponsor organisation address |
173 Binger Strasse, Ingelheim am Rhein, Germany, 55216
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Public contact |
QRPE Processes and Systems Coordination
Clinical Trial Information Disclosure, Boehringer Ingelheim , +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
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Scientific contact |
QRPE Processes and Systems Coordination
Clinical Trial Information Disclosure, Boehringer Ingelheim , +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Mar 2009
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Feb 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit (e.g., spina bifida).
This trial consisted two study periods:
Study Period I, double-blind, dose titration period of 2 weeks.
Study Period II, a double-blind maintenance treatment period of 3 months. In Period II, all patients completing the titration phase entered the 12-week maintenance treatment phase on their randomised dose. The patients stayed on this dose for the duration of the trial.
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Nov 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
Germany: 3
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Country: Number of subjects enrolled |
India: 83
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Country: Number of subjects enrolled |
United States: 13
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Country: Number of subjects enrolled |
Mexico: 20
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Country: Number of subjects enrolled |
Brazil: 7
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Country: Number of subjects enrolled |
Italy: 11
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Country: Number of subjects enrolled |
Russian Federation: 13
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Country: Number of subjects enrolled |
Korea, Democratic People's Republic of: 23
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Country: Number of subjects enrolled |
Philippines: 27
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Country: Number of subjects enrolled |
Ukraine: 13
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Country: Number of subjects enrolled |
South Africa: 16
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Worldwide total number of subjects |
231
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
168
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Adolescents (12-17 years) |
63
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The trial included children from 2-16 years of age,with elevated LPP associated with a known neurologic defect(e.g., spina bifida).The 3 age strata were 2-<5 years,5-<10 years &10-16 years of age.A "Missing" category is unavailable for age group breakdown of enrolled subjects.Hence,1 subject with a missing data is added to age-category"12-17 years. | |||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they met all implemented inclusion/exclusion criteria. Subjects were not randomised to trial drug if any of the specific entry criteria was violated. In this study,231 subjects enrolled,162 subjects randomised &161 subjects treated. | |||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
This trial was double blinded and to maintain the double-blind design, study medications were supplied so that the tamsulosin hydrochloride and placebo capsules were identical.The contents of each placebo capsule had an identical volume to the corresponding capsule of the same dose level of active medication.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo (tamsulosin hydrochloride)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Arm title
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tamsulosin - low dose level | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
tamsulosin hydrochloride (0.025 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to low dose (0.025 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg – 25.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Investigational medicinal product name |
tamsulosin hydrochloride (0.05 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to low dose (0.05 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (25.1 kg – 50.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Investigational medicinal product name |
tamsulosin hydrochloride (0.1 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to low dose (0.1 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (50.1 kg – 100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Arm title
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tamsulosin - medium dose level | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
tamsulosin hydrochloride (0.05 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to medium dose (0.05 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg – 25.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Investigational medicinal product name |
tamsulosin hydrochloride (0.1 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to medium dose (0.1 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (25.1 kg – 50.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Investigational medicinal product name |
tamsulosin hydrochloride (0.2 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to medium dose (0.2 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (50.1 kg – 100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Arm title
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tamsulosin - high dose level | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
tamsulosin hydrochloride (0.1 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to high dose (0.1) mg of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg – 25.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Investigational medicinal product name |
tamsulosin hydrochloride (0.2 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to high dose (0.2 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (25.1 kg– 50.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Investigational medicinal product name |
tamsulosin hydrochloride (0.4 mg)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered to high dose (0.4 mg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (50.1 kg– 100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Baseline characteristics are based on the patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication. |
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
tamsulosin - low dose level
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Reporting group description |
Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
tamsulosin - medium dose level
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Reporting group description |
Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
tamsulosin - high dose level
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Reporting group description |
Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | ||
Reporting group title |
tamsulosin - low dose level
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Reporting group description |
Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | ||
Reporting group title |
tamsulosin - medium dose level
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Reporting group description |
Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects. | ||
Reporting group title |
tamsulosin - high dose level
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Reporting group description |
Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. |
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End point title |
Response defined as patients who decrease their detrusor leak point pressure (LPP) to <40 cm H2O based upon two evaluations on the same day. | ||||||||||||||||||||
End point description |
The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment).
Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram.
Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.
On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Week 14
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [1] - Full analysis set-LPP (FAS-LPP), OT [2] - Full analysis set-LPP (FAS-LPP), OT [3] - Full analysis set-LPP (FAS-LPP), OT [4] - Full analysis set-LPP (FAS-LPP), OT |
|||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
69
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.5388 | ||||||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||||||
Point estimate |
1.38
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
0.5 | ||||||||||||||||||||
upper limit |
3.8 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region.The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
67
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.343 | ||||||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||||||
Point estimate |
0.59
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
0.2 | ||||||||||||||||||||
upper limit |
1.76 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
67
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.5209 | ||||||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||||||
Point estimate |
1.41
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
0.5 | ||||||||||||||||||||
upper limit |
3.97 | ||||||||||||||||||||
Statistical analysis title |
Test of Trend | ||||||||||||||||||||
Statistical analysis description |
A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran−Armitage trend test.
|
||||||||||||||||||||
Comparison groups |
Placebo v tamsulosin - low dose level v tamsulosin - medium dose level v tamsulosin - high dose level
|
||||||||||||||||||||
Number of subjects included in analysis |
135
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.9436 | ||||||||||||||||||||
Method |
Cochran−Armitage trend test | ||||||||||||||||||||
Confidence interval |
|
|||||||||||||||||||||
End point title |
Change from baseline in LPP at Week 14 (end of treatment) | ||||||||||||||||||||
End point description |
Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline and Week 14
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [5] - Full analysis set-LPP(FAS-LPP), OT [6] - Full analysis set-LPP(FAS-LPP), OT [7] - Full analysis set-LPP(FAS-LPP), OT [8] - Full analysis set-LPP(FAS-LPP), OT |
|||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
62
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.3097 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-18.22 | ||||||||||||||||||||
upper limit |
5.83 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
61
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.2676 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-5.28 | ||||||||||||||||||||
upper limit |
18.85 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.6265 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-14.84 | ||||||||||||||||||||
upper limit |
8.98 |
|
|||||||||||||||||||||
End point title |
Percentage Change from baseline in LPP at Week 14 (end of treatment) | ||||||||||||||||||||
End point description |
Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline and Week 14.
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [9] - Full analysis set-LPP(FAS-LPP), OT [10] - Full analysis set-LPP(FAS-LPP), OT [11] - Full analysis set-LPP(FAS-LPP), OT [12] - Full analysis set-LPP(FAS-LPP), OT |
|||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
62
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.4359 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-26.68 | ||||||||||||||||||||
upper limit |
11.58 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
61
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.0658 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-1.19 | ||||||||||||||||||||
upper limit |
37.17 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
63
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.6709 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-23.01 | ||||||||||||||||||||
upper limit |
14.87 |
|
||||||||||||||||||||||||||
End point title |
Response defined as improvement or stabilisation of hydronephrosis based upon the renal ultrasound grading at Week 14 (end of treatment) compared to baseline | |||||||||||||||||||||||||
End point description |
Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.
The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization.
The Full analysis set-renal (FAS-RENAL): Includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.
|
|||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||
End point timeframe |
Baseline and Week 14.
|
|||||||||||||||||||||||||
|
||||||||||||||||||||||||||
Notes [13] - Full analysis set-renal (FAS-RENAL), OT [14] - Full analysis set-renal (FAS-RENAL), OT [15] - Full analysis set-renal (FAS-RENAL), OT [16] - Full analysis set-renal (FAS-RENAL), OT |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo(Left Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-low dose (LD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 63 (31 for tamsulosin-LD & 32 for placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.5672 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo (Left Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-medium dose (MD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 63 (31 in tamsulosin-MD & 32 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.8724 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo (Left Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-high dose (HD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 69 (37 in tamsulosin-HD & 32 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
80
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.7674 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin-low dose vs. Placebo (Right Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-low dose (LD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 64 (33 for tamsulosin-LD & 31 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.5545 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin-medium dose vs. Placebo (Right Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-Medium dose (MD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 61(30 for tamsulosin-MD & 31 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.4774 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin-high dose vs. Placebo (Right Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-High dose (HD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 69 (38 for tamsulosin-HD & 31 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
80
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.8626 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
|
||||||||||||||||||||||||||
End point title |
Response defined as improvement or stabilisation of hydroureter based upon the renal ultrasound at Week 14 (end of treatment) compared to baseline | |||||||||||||||||||||||||
End point description |
Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).
Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.
|
|||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||
End point timeframe |
Baseline and Week 14
|
|||||||||||||||||||||||||
|
||||||||||||||||||||||||||
Notes [17] - Full analysis set-renal (FAS-RENAL), OT [18] - Full analysis set-renal (FAS-RENAL), OT [19] - Full analysis set-renal (FAS-RENAL), OT [20] - Full analysis set-renal (FAS-RENAL), OT |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo (Left Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-low dose (LD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 66 (33 for tamsulosin-LD & 33 for placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.9669 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo (Left Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-medium dose (MD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 65 (32 in tamsulosin-MD & 33 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.9231 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo (Left Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-high dose (HD) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used. The actual number of patients responded is 71 (38 in tamsulosin-HD & 33 in placebo) for Left Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
80
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.636 | |||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo (Right Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-low dose (LD) was compared to placebo. Fisher's exact test was used for this analysis. The actual number of patients responded is 66 (33 for tamsulosin-LD & 33 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 1 | |||||||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin-medium dose vs. Placebo (Right Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-medium dose (MD) was compared to placebo. Fisher's exact test was used for this analysis. The actual number of patients responded is 65 (32 for tamsulosin-MD & 33 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (78) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
78
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.4925 | |||||||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo (Right Kidney) | |||||||||||||||||||||||||
Statistical analysis description |
Patient responded to tamsulosin-high dose (HD) was compared to placebo. Fisher's exact test was used for this analysis. The actual number of patients responded is 71 (38 for tamsulosin-HD & 33 for placebo) for Right Kidney. The pre-specified, automatically calculated number of subjects in FAS-RENAL that is provided in the statistical analysis below (80) does not reflect the actual number.
|
|||||||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
|||||||||||||||||||||||||
Number of subjects included in analysis |
80
|
|||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||||||
P-value |
= 0.4977 | |||||||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||||||
Confidence interval |
|
|||||||||||||||||||||
End point title |
Change from baseline in urine volume at Week 14 | ||||||||||||||||||||
End point description |
Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.
The Full analysis set-catheter (FAS-CATH): Includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline and Week 14
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [21] - Full analysis set-catheter (FAS-CATH), OT [22] - Full analysis set-catheter (FAS-CATH), OT [23] - Full analysis set-catheter (FAS-CATH), OT [24] - Full analysis set-catheter (FAS-CATH), OT |
|||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.1373 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-69.66 | ||||||||||||||||||||
upper limit |
9.78 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.744 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-34.26 | ||||||||||||||||||||
upper limit |
47.74 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.7703 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-32.63 | ||||||||||||||||||||
upper limit |
43.88 |
|
|||||||||||||||||||||
End point title |
Change from baseline in number of times patient was wet at catheterisation | ||||||||||||||||||||
End point description |
Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline and Week 14.
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [25] - Full analysis set-catheter (FAS-CATH), OT [26] - Full analysis set-catheter (FAS-CATH), OT [27] - Full analysis set-catheter (FAS-CATH), OT [28] - Full analysis set-catheter (FAS-CATH), OT |
|||||||||||||||||||||
Statistical analysis title |
tamsulosin - low dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - low dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.0808 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-4.34 | ||||||||||||||||||||
upper limit |
0.26 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - medium dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - medium dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.8244 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-2.64 | ||||||||||||||||||||
upper limit |
2.11 | ||||||||||||||||||||
Statistical analysis title |
tamsulosin - high dose vs. Placebo | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.
|
||||||||||||||||||||
Comparison groups |
tamsulosin - high dose level v Placebo
|
||||||||||||||||||||
Number of subjects included in analysis |
45
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.5045 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-2.96 | ||||||||||||||||||||
upper limit |
1.47 |
|
|||||||||||||||||||||||||||||||
End point title |
Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing,Electorocardiogram (ECG), Laboratory Values, Urinalysis and Cognitive Testing. | ||||||||||||||||||||||||||||||
End point description |
Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, visual acuity, Cognitive Testing, Occurrence of treatment emergent adverse events (AEs ), Premature discontinuation of study drug due to AEs and Urinalysis.
Relevant findings or worsening of baseline conditions were reported as adverse events (AEs).
Treated Set (TS). All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
From first drug administration until 28 days after last study drug administration, upto 160 days
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Notes [29] - Treated Set (TS) [30] - Treated Set (TS) [31] - Treated Set (TS) [32] - Treated Set (TS) |
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Post void residual volume at Week 14 | ||||||||||||||||||||
End point description |
Median change from baseline to Week 14 in post void residual (mL) by study treatment.
Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline and Week 14.
|
||||||||||||||||||||
|
|||||||||||||||||||||
Notes [33] - Treated Set (TS) [34] - Treated Set (TS) [35] - Treated Set (TS) [36] - Treated Set (TS) |
|||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first drug administration until 28 days after last study drug administration, upto 160 days.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
tamsulosin - low dose level
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
tamsulosin - medium dose level
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. One subject randomised to tamsulosin - medium dose level was not treated. Although actual number of subjects started is 40, 39 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
tamsulosin - high dose level
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |