Clinical Trial Results:
A 12 week, multi centre, open label study to evaluate the effect of fesoterodine flexible dosing regimen on the sexual function of women with overactive bladder.
Summary
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EudraCT number |
2010-023851-27 |
Trial protocol |
GB |
Global end of trial date |
17 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Oct 2018
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First version publication date |
13 Oct 2018
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Other versions |
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Summary report(s) |
FINAL STUDY REPORT |
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 |
AMRPhD1
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Additional study identifiers
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ISRCTN number |
ISRCTN40720691 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
King's College Hospital NHS Foundation Trust
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Sponsor organisation address |
Denmark Hill, London, United Kingdom, SE5 9RS
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Public contact |
Angela Rantell, King’s College Hospital NHS Foundation Trust, 0044 0203299 3568, angela.rantell@nhs.net
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Scientific contact |
Angela Rantell, King’s College Hospital NHS Foundation Trust, 0044 0203299 3568, angela.rantell@nhs.net
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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 |
12 Feb 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Jun 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Feb 2017
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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 |
The primary objective is to assess the impact on sexual function, after 12 weeks flexible dose fesoterodine in women with OAB compared to baseline.
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Protection of trial subjects |
At the screening visit the following were performed
• Weight, medical history (including any medication and non-drug treatment) and demographn.
• Sitting blood pressure and pulse.
• Physical examination.
• Urine dipstick test w to exclude blood and infection and Urine pregnancy test for women of child bearing potential.
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Background therapy |
none | ||
Evidence for comparator |
No comparator. | ||
Actual start date of recruitment |
01 May 2012
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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 Kingdom: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
28
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from four clinical sites within the United Kingdom between 12/10/2012 and 10/06/2016. | ||||||||||||||||||
Pre-assignment
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Screening details |
1. Female outpatients aged 18 – 80 years. 2. Overactive bladder symptoms (subject reported) for ≥3 months prior to screening visit according to ICS guidelines. 3. Mean number of Urgency episodes ≥3 per 24 hours as verified by the screening bladder diary prior to baseline / Visit 2. 4. Sexually active Able and willing to complete the micturition | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Arm title
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Full study | ||||||||||||||||||
Arm description |
This was a multi-centre open label study which aimed to enter 132 female subjects with OAB symptoms. Sexual function and efficacy assessments was evaluated via 3-day bladder diaries, questionnaires (KHQ, PISQ-12, SQoL, PAC-QoL, SAGA, PPBC) and urodynamics. Tolerability and safety was evaluated at every visit with recording of adverse events. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Fesoteradine
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Investigational medicinal product code |
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Other name |
TOVIAZ
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
4mg daily for 28 days then option to either continue on same dose or dose escalate to 8mg for the next 56 days
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Full study
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Reporting group description |
This was a multi-centre open label study which aimed to enter 132 female subjects with OAB symptoms. Sexual function and efficacy assessments was evaluated via 3-day bladder diaries, questionnaires (KHQ, PISQ-12, SQoL, PAC-QoL, SAGA, PPBC) and urodynamics. Tolerability and safety was evaluated at every visit with recording of adverse events. |
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End point title |
PISQ-12 [1] | ||||||||
End point description |
Change in item scores of the Pelvic Organ Prolapse. Prolapse and Incontinence Sexual Quality of Life Questionnaire (PISQ-12), PISQ-12 is a self administered questionnaire consisting of 12 items.
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End point type |
Primary
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End point timeframe |
From initial IMP dosing until 12 weeks post dose.
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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: Please see attached document for full results |
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Attachments |
RESULTS |
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No statistical analyses for this end point |
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End point title |
Paired T-Test SQOL-F Total Score [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From commencement of IMP to 12 weeks post.
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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: Please see attached document for full results |
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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 |
Until Week 24 post commencement of dosing.
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Assessment type |
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 |
Whole Trial
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Reporting group description |
All participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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16 Sep 2013 |
Amendment to change IMP supply from clinical trial supplies to commercial stock. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/24369895 |