Overactive BladderPhase 2NCT00343486
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
A Phase 2 study testing Solabegron in people with Overactive Bladder, run by GlaxoSmithKline at 66 sites in 14 countries.
Trial summary
This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solabegron
- How many people
- 240 participants
- Where
- 66 sitesin 14 countries
- Study dates
- May 2006to not given
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
- Body mass index in the range of = 19 kg/m2 to <35 kg/m2.
Who cannot join
- Pregnant
- Of childbearing potential or willing to use specific barrier methods outlined in the protocol.
- Grade III/IV pelvic organ prolapse with or without cystocele.
- History of interstitial cystitis or bladder related pain.
- 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.
Show all 17Show fewer
- 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.
- Current or history of Urinary Tract Infection.
- Diabetes insipidus.
- History of myocardial infarction, unstable angina, or Congestive heart failure.
- Chronic severe constipation.
- 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.
- Received any investigational product within 30 days of enrollment into the study.
Trial locations and contacts
66 sites in 14 countries.
66 sites in 14 countries
Germany13 sites
GSK Investigational Site
Berlin, State of Berlin, 10787
GSK Investigational Site
Berlin, State of Berlin, 13125
GSK Investigational Site
Dessau, Saxony-Anhalt, 06844
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Hagenow, Brandenburg, 19230
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22143
GSK Investigational Site
Leipzg, Saxony, 04109
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04105
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Marburg, Hesse, 35039
GSK Investigational Site
Schwedt, Brandenburg, 16303
Spain8 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Donostia / San Sebastian, 20014
GSK Investigational Site
Getafe, 28905
GSK Investigational Site
Granada, 18012
GSK Investigational Site
Marbella, 29600
GSK Investigational Site
Valencia, 46009
GSK Investigational Site
Valencia, 46010
GSK Investigational Site
Vigo (Pontevedra), 30211
Argentina7 sites
GSK Investigational Site
Av Córdoba 2424, Buenos Aires, 1120
GSK Investigational Site
Bahía Blanca, Buenos Aires, 8001
GSK Investigational Site
Buenos Aires, C1113AAH
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1406CPC
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, C1425BGV
GSK Investigational Site
Córdoba, Córdoba Province, 5000
GSK Investigational Site
Córdoba, Córdoba Province, 5016
Netherlands6 sites
GSK Investigational Site
Apeldoorn, 7314 ET
GSK Investigational Site
Emmen, 7824 AA
GSK Investigational Site
Enschede, 7511JX
GSK Investigational Site
Nijmegen, 6525 GA
GSK Investigational Site
Tilburg, 5022 GC
GSK Investigational Site
Utrecht, 3584 CJ
Australia5 sites
GSK Investigational Site
Caboolture, Queensland, 4510
GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
Randwick, New South Wales, 2031
GSK Investigational Site
Spring Hill, Victoria, 4000
France5 sites
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Paris, 75571
GSK Investigational Site
Paris, 75970
GSK Investigational Site
Saint-Genis-Laval, 69230
GSK Investigational Site
Suresnes, 92151
New Zealand4 sites
GSK Investigational Site
Christchurch, 8014
GSK Investigational Site
Dunedin, 9016
GSK Investigational Site
Tauranga, 3140
GSK Investigational Site
Whangarei, 0112
South Korea4 sites
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Seoul, 138-736
Slovenia3 sites
GSK Investigational Site
Celje, 3000
GSK Investigational Site
Ljubljana, 1000
GSK Investigational Site
Slovenj Gradec, 2380
South Africa3 sites
GSK Investigational Site
Bloemfontein, 9300
GSK Investigational Site
Cape Town, 8001
GSK Investigational Site
Somerset West, 7130
Taiwan3 sites
GSK Investigational Site
Hualien City, 970
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taipei, 112
Finland2 sites
GSK Investigational Site
Oulu, 90100
GSK Investigational Site
Tampere, 33521
Poland2 sites
GSK Investigational Site
Lodz, 90-710
GSK Investigational Site
Lublin, 20-954
About this study
Official title: An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as Well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women With Overactive Bladder
This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- Solabegron
- 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.
SolabegronDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Secondary outcomes (1)
Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- 240 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343486
- Sponsor's protocol ID
- B3P104833
- Other IDs
- M06-1605.
- Status last verified
- May 2009
- First submitted
- 21 Jun 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as Well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00343486
- Acronym / sponsor ID
- B3P104833
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 23 Jun 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 study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
- Body mass index in the range of = 19 kg/m2 to <35 kg/m2.
Key exclusion criteria (17 listed)
- Pregnant
- Of childbearing potential or willing to use specific barrier methods outlined in the protocol.
- Grade III/IV pelvic organ prolapse with or without cystocele.
- History of interstitial cystitis or bladder related pain.
- Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
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 |
|---|---|---|
| Solabegron | Drug | – |
Primary outcome
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
1 secondary outcome
Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.
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 18 May 2009.
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Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
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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, MD study director
GlaxoSmithKline
66 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solabegron in people with Overactive Bladder, run by GlaxoSmithKline at 66 sites in 14 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 2 inclusion and 17 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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Germany, Spain, Argentina, Netherlands, Australia and 9 more countries. 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 reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment. 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 18 May 2009.