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.

Trial information Top of page
Trial identification
Sponsor protocol code	08/0316
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	University College London
Sponsor organisation address	Gower Street, London, United Kingdom,
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
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
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	14 Oct 2014
Is this the analysis of the primary completion data?	Yes
Primary completion date	14 Oct 2014
Global end of trial reached?	Yes
Global end of trial date	14 Oct 2014
Was the trial ended prematurely?	Yes
General information about the trial
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.
Protection of trial subjects	No specific measures in place.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	01 Jun 2012
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	United Kingdom: 2
Worldwide total number of subjects	2
EEA total number of subjects	2
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	2
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	2 subjects were enrolled onto the study
Period 1
Period 1 title	Baseline and main trial period (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
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.
Arms
Are arms mutually exclusive	Yes
Arm title	Test Drug
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Nitrofurantoin
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg twice daily for six weeks
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg twice daily for six weeks
Number of subjects in period 1 Test Drug Placebo Started 1 1 Completed 1 1

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Test Drug
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-

End points Top of page

Primary: Primary Endpoint Top of page
End point title	Primary Endpoint [1]
End point description
End point type	Primary
End point timeframe	Only 2 patients were enrolled in the trial. No data analysis was done. The trial ended early due to recruitment problems.
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.
End point values Test Drug Placebo Number of subjects analysed 0 [2] 0 [3] Units: 0     number (not applicable)
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
No statistical analyses for this end point

Primary: Primary Endpoint Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	Adverse events were recorded at all study visits.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	22.0
Reporting groups
Reporting group title	Study Drug
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Serious adverse events Study Drug Placebo Total subjects affected by serious adverse events      subjects affected / exposed 0 / 1 (0.00%) 0 / 1 (0.00%)      number of deaths (all causes) 0 0      number of deaths resulting from adverse events 0 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events Study Drug Placebo Total subjects affected by non serious adverse events      subjects affected / exposed 0 / 1 (0.00%) 0 / 1 (0.00%)
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.

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
04 Jul 2011	Change in incl/excl. criteria, new SmPC, clarification on IMPD.
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

More information Top of page