Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01042236
First received: January 4, 2010
Last updated: July 20, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Urinary Incontinence |
Drug: Fesoterodine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Crossover Study Of The Efficacy Of Fesoterodine In Increasing Urethral Pressure In Stress Urinary Incontinence Patients. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Secondary Outcome Measures:
- Change From Baseline in Closing Urethral Pressure at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
- Change From Baseline in Opening Urethral Elastance at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
- Change From Baseline in Closing Urethral Elastance at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
- Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
- Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
- Stress Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
- Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
- Urgency Urinary Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
- Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
- Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
| Enrollment: | 22 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Fesoterodine
Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
Other Name: Toviaz
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female, 18 - 65 years
- SUI symptoms for longer than 3 months
- Subjects must be non-pregnant and not breastfeeding
Exclusion Criteria:
- Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence)
- Subjects taking medication with effects on the bladder or urinary tract
- Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01042236 History of Changes |
| Other Study ID Numbers: | A0221064 |
| Study First Received: | January 4, 2010 |
| Results First Received: | June 8, 2011 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Denmark: Danish Medical Authority |
Keywords provided by Pfizer:
|
Phase 2 stress urinary incontinence Fesoterodine |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013