Clinical Trial Results:
A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis.
Summary
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EudraCT number |
2009-017939-18 |
Trial protocol |
GB |
Global end of trial date |
14 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Oct 2019
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First version publication date |
13 Oct 2019
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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 |
08/0316
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University College London
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Sponsor organisation address |
Gower Street, London, United Kingdom,
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Public contact |
Joint Research Office, Gower Street, London , United Kingdom, WC1E 6BT, Joint Research Office, Gower Street, London , United Kingdom, WC1E 6BT, ctimps@ucl.ac.uk
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Scientific contact |
Joint Research Office, Gower Street, London , United Kingdom, WC1E 6BT, Joint Research Office, Gower Street, London , United Kingdom, WC1E 6BT, ctimps@ucl.ac.uk
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Oct 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The aim of this study is to determine whether treatment with Nitrofurantoin improves average voided volume in MS and non-MS patients presenting with symptoms of overactive bladder and pyuria with a negative mid stream urine culture.
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Protection of trial subjects |
No specific measures in place.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 Kingdom: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
2
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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 |
2 subjects were enrolled onto the study | |||||||||
Period 1
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Period 1 title |
Baseline and main trial 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 |
Only 2 patients were enrolled. Estimated numbers in each treatment arm are provided based on randomisation scheme.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test Drug | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nitrofurantoin
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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 |
100 mg twice daily for six weeks
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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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 |
100 mg twice daily for six weeks
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End points reporting groups
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Reporting group title |
Test Drug
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Primary Endpoint [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Only 2 patients were enrolled in the trial. No data analysis was done. The trial ended early due to recruitment problems.
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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: Only 2 patients were enrolled in the trial. No data analysis was done. The trial ended early due to recruitment problems. |
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Notes [2] - Only 2 patients were enrolled in the trial. No data analysis was done. The trial ended early due to [3] - Only 2 patients were enrolled in the trial. No data analysis was done. The trial ended early due to |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events were recorded at all study visits.
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
Study Drug
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Only 2 patients were enrolled in the trial. No SAEs were reported. |
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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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04 Jul 2011 |
Change in incl/excl. criteria, new SmPC, clarification on IMPD.
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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 |