Clinical Trial Results:
An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
Summary
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EudraCT number |
2014-004161-24 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
20 Dec 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
30 May 2016
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First version publication date |
12 Jul 2015
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Other versions |
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 |
A0221066
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00857896 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 May 2011
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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 |
20 Dec 2010
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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 determine the pharmacokinetics of 5-hydroxy-methyltolterodine (5-HMT) in pediatric overactive bladder (OAB) subjects aged 8-17 years.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Mar 2009
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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 |
United States: 21
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Worldwide total number of subjects |
21
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EEA total number of subjects |
0
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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) |
6
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Adolescents (12-17 years) |
15
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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 |
- | ||||||||||
Pre-assignment
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Screening details |
Total 21 subjects were enrolled in 7 centres of United States. Study started from 20 Mar 2009 and completed on 20 Dec 2010. | ||||||||||
Period 1
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Period 1 title |
Baseline to Week 4
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Fesoterodine | ||||||||||
Arm description |
Fesoterodine 4 milligram (mg) tablet from Baseline to Week 4, escalated to 8 mg tablet for Weeks 5 to 8. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Fesoterodine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Fesoterodine 4 mg tablet was administered once daily (QD) from Baseline to Week 4.
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Period 2
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Period 2 title |
Week 5 to Week 8
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Fesoterodine | ||||||||||
Arm description |
Fesoterodine 4 mg tablet from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Fesoterodine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Fesoterodine 8 mg tablet QD for Weeks 5 to 8.
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Baseline characteristics reporting groups
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Reporting group title |
Fesoterodine
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Reporting group description |
Fesoterodine 4 milligram (mg) tablet from Baseline to Week 4, escalated to 8 mg tablet for Weeks 5 to 8. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fesoterodine
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Reporting group description |
Fesoterodine 4 milligram (mg) tablet from Baseline to Week 4, escalated to 8 mg tablet for Weeks 5 to 8. | ||
Reporting group title |
Fesoterodine
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Reporting group description |
Fesoterodine 4 mg tablet from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8. |
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End point title |
Absorption Rate Constant (Ka) [1] | ||||||||
End point description |
Pharmacokinetic (PK) concentration population: randomized and treated subjects who had at least 1 concentration during the study.
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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No statistical analyses for this end point |
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End point title |
Apparent Volume of Distribution (VC/F) [2] | ||||||||
End point description |
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling. PK concentration population.
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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No statistical analyses for this end point |
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End point title |
Area Under the plasma drug concentration time curve (AUC) [3] | ||||||||
End point description |
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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Notes [4] - Not analyzed due to the limited amount of data available. |
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No statistical analyses for this end point |
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End point title |
Time to Reach Maximum Observed Plasma Concentration (Tmax) [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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Notes [6] - Not analyzed due to the limited amount of data available. |
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No statistical analyses for this end point |
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End point title |
Maximum Observed Plasma Concentration (Cmax) [7] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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Notes [8] - Not analyzed due to the limited amount of data available. |
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No statistical analyses for this end point |
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End point title |
Plasma Decay Half-Life (t1/2) [9] | ||||||||
End point description |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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Notes [10] - Not analyzed due to the limited amount of data available. |
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No statistical analyses for this end point |
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End point title |
Apparent Oral Clearance (CL/F) [11] | ||||||||
End point description |
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK Concentration population.
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End point type |
Primary
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End point timeframe |
Day 28 and Day 56
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Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The plasma concentration-time data were analyzed by population PK modeling to estimate the 5-HMT PK parameters, for which descriptive summary statistics such as point estimate, relative standard error and 95% confidence intervals were reported |
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No statistical analyses for this end point |
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End point title |
Post-void Residual (PVR) Volume | ||||||||||||||
End point description |
Volume of urine remaining in the bladder immediately after urination. Safety Population: all subjects who were known to have received study medication, n = subjects not performing clean intermittent bladder catheterization (CIC) at specified time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 4, Week 8 post-dose
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Notes [12] - Subjects not performing CIC. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to 7 days after the last dose of study drug
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Adverse event reporting additional description |
The same event may appear as both an adverse event (AE) and a serious AE (SAE). An event may be categorized as serious in one subject and as nonserious in an other subject. EU BR specific AE tables were generated separately as per EU format using latest coding.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Fesoterodine 4 mg
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Reporting group description |
Fesoterodine 4 mg tablet QD anytime during the study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fesoterodine 8 mg
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Reporting group description |
Fesoterodine 8 mg tablet QD anytime during the study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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23 Nov 2009 |
Inclusion criteria of age was changed from 8-11 years to 8-17 years. |
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28 Jul 2010 |
Inclusion criteria of total body weight of greater than (>) 35 kg was changed to total body weight of >25 kg. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |