Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
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| ClinicalTrials.gov Identifier: NCT00561951 |
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Recruitment Status :
Completed
First Posted : November 21, 2007
Results First Posted : September 9, 2010
Last Update Posted : July 14, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder | Drug: fesoterodine fumarate Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 951 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder. |
| Study Start Date : | November 2007 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Fesoterodine fumarate 4 mg (Double-Blind) |
Drug: fesoterodine fumarate
4mg tablets OD for 12 weeks |
| Placebo Comparator: Placebo (Double-Blind) |
Drug: Placebo
Corresponding placebo tablets OD for 12 weeks |
| Experimental: Fesoterodine fumarate 8 mg (Double-Blind) |
Drug: fesoterodine fumarate
8mg tablets OD for 12 weeks |
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline.
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.
- Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline.
- Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at each visit minus mean at Baseline.
- Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.
- Change From Baseline in Mean Voided Volume Per Micturition at Week 12. [ Time Frame: Baseline to Week 12 ]
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.
- Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). [ Time Frame: Baseline to Week12 ]
King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Baseline to Week 12 ]
The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).
The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.
Change: mean at Week 12 minus mean at Baseline.
- Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Baseline to Week 12 ]
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
- No problems at all
- Some very minor problems
- Some minor problems
- Some moderate problems
- Severe problems
- Many severe problems
Change: mean at Week 12 minus mean at Baseline.
- The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Baseline to Week 12 ]
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
- No problems at all
- Some very minor problems
- Some minor problems
- Some moderate problems
- Severe problems
- Many severe problems
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.
Exclusion Criteria:
- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- Patient has a known neurological disease influencing bladder function.
- Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561951
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| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00561951 |
| Other Study ID Numbers: |
A0221005 |
| First Posted: | November 21, 2007 Key Record Dates |
| Results First Posted: | September 9, 2010 |
| Last Update Posted: | July 14, 2011 |
| Last Verified: | July 2011 |
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Urinary Bladder, Overactive 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 |
Fesoterodine Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |