A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.
- Clinically significant stress urinary incontinence
- History or evidence of any relevant confounding urological or neurological disease
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence. | |||
| Official Title ICMJE | An 8-Week, Multi-Centre,Randomised Double-Blind, Placebo Controlled, Parallel Group Study To Evaluate The Efficacy,Toleration And Safety Of (+)- [S,S]- Reboxetine In The Treatment Of Stress Urinary Incontinence (SUI) In Women. | |||
| Brief Summary | A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Urinary Incontinence, Stress | |||
| Intervention ICMJE | Drug: SS-RBX | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 402 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 2006 | |||
| Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00138749 | |||
| Other Study ID Numbers ICMJE | A6061023 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | April 2011 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
