Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

NCT00343486 | Completed Phase 2

• 2 other identifiers: B3P104833M06-1605.
• Study Type: interventional
• Target: 240
• Locations: 14 countries
• Sites: 66

Brief Summary

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

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Solabegron DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (66)

GSK Investigational Site

Av Córdoba 2424, Buenos Aires, 1120, Argentina

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GSK Investigational Site

Bahía Blanca, Buenos Aires, 8001, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1406CPC, Argentina

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Ciudad de Buenos Aires, Buenos Aires, C1425BGV, Argentina

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GSK Investigational Site

Córdoba, Córdoba Province, 5000, Argentina

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GSK Investigational Site

Córdoba, Córdoba Province, 5016, Argentina

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GSK Investigational Site

Buenos Aires, C1113AAH, Argentina

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GSK Investigational Site

Randwick, New South Wales, 2031, Australia

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Caboolture, Queensland, 4510, Australia

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GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

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Carlton, Victoria, 3053, Australia

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Spring Hill, Victoria, 4000, Australia

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Oulu, 90100, Finland

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Tampere, 33521, Finland

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Lyon, 69437, France

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Paris, 75571, France

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GSK Investigational Site

Paris, 75970, France

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GSK Investigational Site

Saint-Genis-Laval, 69230, France

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GSK Investigational Site

Suresnes, 92151, France

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GSK Investigational Site

Hagenow, Brandenburg, 19230, Germany

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Schwedt, Brandenburg, 16303, Germany

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Hamburg, Hamburg, 20249, Germany

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Hamburg, Hamburg, 22143, Germany

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Marburg, Hesse, 35039, Germany

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Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Leipzg, Saxony, 04109, Germany

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Leipzig, Saxony, 04103, Germany

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GSK Investigational Site

Leipzig, Saxony, 04105, Germany

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GSK Investigational Site

Dessau, Saxony-Anhalt, 06844, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Berlin, State of Berlin, 10787, Germany

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Berlin, State of Berlin, 13125, Germany

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Riga, LV 1002, Latvia

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Apeldoorn, 7314 ET, Netherlands

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Emmen, 7824 AA, Netherlands

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Enschede, 7511JX, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Tilburg, 5022 GC, Netherlands

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Utrecht, 3584 CJ, Netherlands

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Christchurch, 8014, New Zealand

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Dunedin, 9016, New Zealand

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Tauranga, 3140, New Zealand

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Whangarei, 0112, New Zealand

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Lodz, 90-710, Poland

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Lublin, 20-954, Poland

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GSK Investigational Site

Celje, 3000, Slovenia

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Ljubljana, 1000, Slovenia

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Slovenj Gradec, 2380, Slovenia

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GSK Investigational Site

Bloemfontein, 9300, South Africa

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Cape Town, 8001, South Africa

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Somerset West, 7130, South Africa

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GSK Investigational Site

Seoul, 120-752, South Korea

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GSK Investigational Site

Seoul, 135-710, South Korea

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GSK Investigational Site

Seoul, 137-701, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Donostia / San Sebastian, 20014, Spain

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GSK Investigational Site

Getafe, 28905, Spain

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GSK Investigational Site

Granada, 18012, Spain

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GSK Investigational Site

Marbella, 29600, Spain

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GSK Investigational Site

Valencia, 46009, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Vigo (Pontevedra), 30211, Spain

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GSK Investigational Site

Hualien City, 970, Taiwan

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GSK Investigational Site

Taichung, 404, Taiwan

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GSK Investigational Site

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

solabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 23, 2006
• Study Start: May 1, 2006
• Last Updated: May 18, 2009

Record last verified: 2009-05

Locations

ZA (3); PL (2); AU (5); KR (4); FI (2); DE (13); LA (1); ES (8); TW (3); FR (5); NZ (4); NL (6); SL (3); AR (7)