Incontinence, Urinary and Urinary Bladder, OveractivePhase 2NCT00321477
A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder
A Phase 2 study testing GW679769 oral tablets in people with Incontinence, Urinary and Urinary Bladder, Overactive and Overactive Bladder, run by GlaxoSmithKline at 58 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Incontinence, Urinary and Urinary Bladder, Overactive, Overactive Bladder
- What is being tested?
- GW679769 oral tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Dec 2005to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States41 sites
GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
GSK Investigational Site
Clearwater, Florida, 33761
GSK Investigational Site
Dallas, Texas, 75234
GSK Investigational Site
Denver, Colorado, 80210
GSK Investigational Site
Denver, Colorado, 80211
GSK Investigational Site
Fort Myers, Florida, 33916
GSK Investigational Site
Huntsville, Alabama, 35801
GSK Investigational Site
Indianapolis, Indiana, 46254
GSK Investigational Site
Jeffersonville, Indiana, 47130
GSK Investigational Site
Kingston, New York, 12401
GSK Investigational Site
La Mesa, California, 91942
GSK Investigational Site
Lancaster, Pennsylvania, 17604
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Longmont, Colorado, 80501
GSK Investigational Site
Melrose Park, Illinois, 60160
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Modesto, California, 95350
GSK Investigational Site
Nashville, Tennessee, 37232
GSK Investigational Site
Newburgh, Indiana, 47630
GSK Investigational Site
Ocala, Florida, 34474
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Peoria, Arizona, 85381 - 4828
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Poughkeepsie, New York, 12601
GSK Investigational Site
Providence, Rhode Island, 02906
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
San Bernardino, California, 92404
GSK Investigational Site
Sarasota, Florida, 34237
GSK Investigational Site
Sellersville, Pennsylvania, 18960
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
Springfield, Oregon, 97477
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Torrance, California, 90506
GSK Investigational Site
Waterbury, Connecticut, 06708
GSK Investigational Site
Winston-Salem, North Carolina, 27103
Canada17 sites
GSK Investigational Site
Barrie, Ontario, L4M 7G1
GSK Investigational Site
Fredericton, New Brunswick, E3B 5B8
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H3
GSK Investigational Site
Kentville, Nova Scotia, B4N 4K9
GSK Investigational Site
Kitchener, Ontario, N2M 5N4
GSK Investigational Site
Newmarket, Ontario, L3X 1W1
GSK Investigational Site
North Bay, Ontario, P1B 4Z2
GSK Investigational Site
Oakville, Ontario, L6H 3P1
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1S 2L6
GSK Investigational Site
Saint John, New Brunswick, E2L 4L2
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Surrey, British Columbia, V3V 1N1
GSK Investigational Site
Toronto, Ontario, M6A 3B5
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Victoria, British Columbia, V8T 5G1
GSK Investigational Site
Victoria, British Columbia, V8V 3N1
About this study
Official title: NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder Symptoms
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.
Read the detailed description
A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder
- Being tested
- GW679769 oral tablets
- Keywords
- Overactive Bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769 oral tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs
Measured: 12 weeks
Secondary outcomes (1)
Change from baseline to Weeks 6 and 12 in the following endpoints: Number of micturitions/24 hrs Number of urgency episodes/24 hrs Number of nocturia episodes/24 hrs
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startDec 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, Urinary and Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321477
- Sponsor's protocol ID
- NKB105022
- Status last verified
- Jan 2017
- First submitted
- 1 May 2006
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder Symptoms
- ClinicalTrials.gov ID
- NCT00321477
- Acronym / sponsor ID
- NKB105022
- Keywords
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 oral tablets | Drug | – |
Primary outcome
Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs
Time frame: 12 weeks
1 secondary outcome
Change from baseline to Weeks 6 and 12 in the following endpoints: Number of micturitions/24 hrs Number of urgency episodes/24 hrs Number of nocturia episodes/24 hrs
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW679769 oral tablets in people with Incontinence, Urinary and Urinary Bladder, Overactive and Overactive Bladder, run by GlaxoSmithKline at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.