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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00343486




Registration number
NCT00343486
Ethics application status
Date submitted
21/06/2006
Date registered
23/06/2006
Date last updated
18/05/2009

Titles & IDs
Public title
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
Scientific 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
Secondary ID [1] 0 0
M06-1605.
Secondary ID [2] 0 0
B3P104833
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Solabegron

Treatment: Drugs: Solabegron
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Caboolture
Recruitment hospital [3] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [4] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [5] 0 0
GSK Investigational Site - Spring Hill
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4510 - Caboolture
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
4000 - Spring Hill
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdova
Country [3] 0 0
Finland
State/province [3] 0 0
Oulu
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Finland
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Tampere
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France
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Lyon
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France
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Paris Cedex 12
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France
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Paris Cedex 20
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France
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Saint Genis Laval
Country [9] 0 0
France
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Suresnes
Country [10] 0 0
Germany
State/province [10] 0 0
Brandenburg
Country [11] 0 0
Germany
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Hessen
Country [12] 0 0
Germany
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Sachsen-Anhalt
Country [13] 0 0
Germany
State/province [13] 0 0
Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Netherlands
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Apeldoorn
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Netherlands
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Emmen
Country [20] 0 0
Netherlands
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Enschede
Country [21] 0 0
Netherlands
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Nijmegen
Country [22] 0 0
Netherlands
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Tilburg
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Netherlands
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Utrecht
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New Zealand
State/province [24] 0 0
Christchurch
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New Zealand
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Dunedin
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New Zealand
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Tauranga
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New Zealand
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Whangarei
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Poland
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Lodz
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Poland
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Lublin
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Slovenia
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Celje
Country [31] 0 0
Slovenia
State/province [31] 0 0
Ljubljana
Country [32] 0 0
Slovenia
State/province [32] 0 0
Slovenj Gradec
Country [33] 0 0
South Africa
State/province [33] 0 0
Bloemfontein
Country [34] 0 0
South Africa
State/province [34] 0 0
Cape Town
Country [35] 0 0
South Africa
State/province [35] 0 0
Somerset West
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Spain
State/province [36] 0 0
Barcelona
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Spain
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Getafe
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Spain
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Granada
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Spain
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Marbella
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Spain
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San Sebastian
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Spain
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Valencia
Country [42] 0 0
Spain
State/province [42] 0 0
Vigo (Pontevedra)
Country [43] 0 0
Taiwan
State/province [43] 0 0
Hualien
Country [44] 0 0
Taiwan
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Taichung
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will test the effectiveness and safety of two doses of solabegron against placebo
in reducing the symptoms of overactive bladder.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00343486
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries