Last updated: 11/04/2018 09:40:06
A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder symptoms
Trial description: This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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
Secondary outcomes:
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)
Interventions:
Drug: GW679769 oral tablets
Enrollment:
169
Observational study model:
Not applicable
Primary completion date:
2007-24-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Incontinence, Urinary and Urinary Bladder, Overactive
Product
casopitant
Collaborators
Not applicable
Study date(s)
December 2005 to February 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 75 years
Accepts healthy volunteers
No
- 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.
Inclusion and exclusion criteria
Inclusion 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.
- 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.
Exclusion criteria:
- 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)
Location
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
Status
Study Complete
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17604
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Longmont, Colorado, United States, 80501
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 91942
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M6A 3B5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12205
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80210
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40509
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98166
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37232
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
Status
Study Complete
Location
GSK Investigational Site
Oshawa, Ontario, Canada, L1H 1B9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Fredericton, New Brunswick, Canada, E3B 5B8
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34237
Status
Study Complete
Location
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80211
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90506
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3N1
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46254
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30309
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Sellersville, Pennsylvania, United States, 18960
Status
Study Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H2X 1N8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
Status
Study Complete
Location
GSK Investigational Site
San Bernardino, California, United States, 92404
Status
Study Complete
Location
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 4L2
Status
Study Complete
Location
GSK Investigational Site
Bayshore, New York, United States, 11706
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newburgh, Indiana, United States, 47630
Status
Study Complete
Location
GSK Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
GSK Investigational Site
Springfield, Oregon, United States, 97477
Status
Study Complete
Location
GSK Investigational Site
Guelph, Ontario, Canada, N1H 5J1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Modesto, California, United States, 95350
Status
Study Complete
Location
GSK Investigational Site
Kentville, Nova Scotia, Canada, B4N 4K9
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Fort Myers, Florida, United States, 33916
Status
Study Complete
Location
GSK Investigational Site
Aurora, Colorado, United States, 80012
Status
Study Complete
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
Location
GSK Investigational Site
Staten Island, New York, United States, 10304
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-24-02
Actual study completion date
2007-24-02
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.
Additional information about the trial
Additional information
Not applicable
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