A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder
Trial overview
Percentage change from Baseline to Week 12 in the number of incontinence episodes per 24 hours (h)
Timeframe: Baseline (Day 0, Visit 2) and Week 12
Percentage change from Baseline to Week 6 in the number of incontinence episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2) and Week 6
Percentage change from Baseline to Week 6 and 12 in number of urge incontinence episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage change from Baseline to Week 6 and 12 in number of urgency episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage change from Baseline to Weeks 6 and 12 in number of micturitions per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage change from Baseline to Weeks 6 and 12 in number of nocturia episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage change from Baseline to Weeks 6 and 12 in number of nocturnal voids per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in the number of incontinence episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in the number of urge incontinence episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in the number of urgency episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in the number of micturitions per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in the number of nocturia episodes per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in the number of nocturnal voids per 24 h
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in mean volume voided per micturition
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline maximum volume voided per micturition to maximum volume voided per micturition at Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in mean urgency visual analog scale (VAS) score
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in median urgency VAS score
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in worst severity (WS) urgency VAS score
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in sum urgency VAS score
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in Participant Perception of Bladder Condition (PPBC)
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Change from Baseline to Weeks 6 and 12 in Urgency Perception Scale (UPS) score
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with continence and at least a 25% and 50% reduction in number of episodes of incontinence per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with continence and at least a 25% and 50% reduction in number of episodes of incontinence per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with no episodes of urge incontinence and at least a 25% and 50% reduction in number of episodes of urge incontinence per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with no episodes of urge incontinence and at least a 25% and 50% reduction in number of episodes of urge incontinence per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with no episodes of urgency and at least a 25% and 50% reduction in number of episodes of urgency per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with no episodes of urgency and at least a 25% and 50% reduction in number of episodes of urgency per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with no episodes of nocturia and at least a 25% and 50% reduction in number of episodes of nocturia per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with no episodes of nocturia and at least a 25% and 50% reduction in number of episodes of nocturia per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with no nocturnal void and at least a 25% and 50% reduction in number of nocturnal voids per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Randomization Visit, Day 0, Visit 2), Week 6 and Week 12
Number of participants with no nocturnal void and at least a 25% and 50% reduction in number of nocturnal voids per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with < 8 micturitions per 24 h and at least a 25% and 50% reduction in the number of micturitions per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with <8 micturitions per 24 h and at least a 25% and 50% reduction in the number of micturitions per 24 h from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Percentage of participants with any improvement in PPBC score from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with any improvement in PPBC score from Baseline to Weeks 6 and 12
Timeframe: Baseline (Day 0, Visit 2), Week 6 and Week 12
Number of participants with any adverse event (AE), serious adverse event (SAE) or death
Timeframe: Up to Follow-up (Week 14)
Number of participants with AE of maximum intensity of mild, moderate and severe
Timeframe: Up to Follow-up (Week 14)
Number of participants with clinical chemistry values of potential clinical concern at any time post-Baseline
Timeframe: Baseline (Day 0, Visit 2) up to Follow-up (Week 14)
Number of participants with hematology values of potential clinical concern at any time post-Baseline
Timeframe: Baseline (Day 0, Visit 2) up to Follow-up (Week 14)
Number of participants with vital sign values of potential clinical concern at any time post-Baseline
Timeframe: Baseline (Day 0, Visit 2) up to Follow-up (Week 14)
Number of participants with normal and abnormal (both not clinically significant and clinically significant) electrocardiogram (ECG) findings at any Visit post-Baseline
Timeframe: Baseline (Screening, Visit 1) up to Follow-up (Week 14)
Number of participants with maximum post-void residual (PVR) volume at any time post-Baseline
Timeframe: Baseline (Screening, Visit 1) up to Week 12
Population pharmacokinetic parameters of GW679769 and its primary metabolite (GSK525060)
Timeframe: Week 2 (15 minutes pre dose and 1-3 h post dose [dose administered at the clinic]), Week 6 (3-6 h post dose), Week 9 (15 minutes pre dose and 1-3 h post dose [dose administered at the clinic]) and Week 12 (6-12 h post dose).
Relationships between predicted exposures of GW679769 and its primary metabolite (GSK525060) with relevant efficacy and safety endpoints
Timeframe: Week 2 (15 minutes pre dose and 1-3 h post dose [dose administered at the clinic]), Week 6 (3-6 h post dose), Week 9 (15 minutes pre dose and 1-3 h post dose [dose administered at the clinic]) and Week 12 (6-12 h post dose)
Participation criteria
- Female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
- Must not be pregnant.
- Stage III/IV pelvic organ prolapse with or without cystocele.
- History of interstitial cystitis or bladder related pain.
- Female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
- Must not be pregnant.
- Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- Body weight in the range of = 45 kg and <100 kg.
- Stage III/IV pelvic organ prolapse with or without cystocele.
- History of interstitial cystitis or bladder related pain.
- Subjects with stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
- History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.
- Subjects with urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).
- Nocturnal enuresis only.
- Urinary retention, or other evidence of poor detrusor function.
- History of prior anti-incontinence surgery.
- History of radiation cystitis or a history of pelvic irradiation.
- Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
- Participated in any clinical trial of an investigation drug that may affect urinary function within 3 months of enrollment into the study.
- Received any investigational product within 30 days of enrollment into the study.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.