A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Overactive Bladder Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911937
• Other study ID #: A0221048
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 963
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)

• Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)

• Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

• A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia

• Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
Fesoterodine 4mg and 8 mg tablets taken daily.
• Placebo
Placebo sham 4mg and 8 mg tables taken daily.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Anderson	South Carolina
United States	Pfizer Investigational Site	Annapolis	Maryland
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Bala-Cynwyd	Pennsylvania
United States	Pfizer Investigational Site	Bonita Springs	Florida
United States	Pfizer Investigational Site	Bridgeville	Pennsylvania
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Brooksville	Florida
United States	Pfizer Investigational Site	Bryan	Texas
United States	Pfizer Investigational Site	Burlington	North Carolina
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chaska	Minnesota
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Coeur d'Alene	Idaho
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Concord	North Carolina
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	DeFuniak Springs	Florida
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Destin	Florida
United States	Pfizer Investigational Site	Dover	Delaware
United States	Pfizer Investigational Site	East Greenwich	Rhode Island
United States	Pfizer Investigational Site	Fall River	Massachusetts
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Farmington	Connecticut
United States	Pfizer Investigational Site	Fort Wayne	Indiana
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Garden City	New York
United States	Pfizer Investigational Site	Goodyear	Arizona
United States	Pfizer Investigational Site	Hamilton	New Jersey
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntersville	North Carolina
United States	Pfizer Investigational Site	Hyannis	Massachusetts
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	Jeffersonville	Indiana
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Kingston	New York
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Lansdale	Pennsylvania
United States	Pfizer Investigational Site	Leesburg	Florida
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Litchfield Park	Arizona
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Madisonville	Kentucky
United States	Pfizer Investigational Site	Manlius	New York
United States	Pfizer Investigational Site	Menomonee Falls	Wisconsin
United States	Pfizer Investigational Site	Milan	Tennessee
United States	Pfizer Investigational Site	Milford	Massachusetts
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Mount Pleasant	South Carolina
United States	Pfizer Investigational Site	Mount Sterling	Kentucky
United States	Pfizer Investigational Site	Mountlake Terrace	Washington
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Bedford	Massachusetts
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Newton	Kansas
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Norwalk	Connecticut
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Pawtucket	Rhode Island
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Poughkeepsie	New York
United States	Pfizer Investigational Site	Pratt	Kansas
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Roseville	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Petersburg	Florida
United States	Pfizer Investigational Site	Salisbury	North Carolina
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tarzana	California
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Warwick	Rhode Island
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	West Des Moines	Iowa
United States	Pfizer Investigational Site	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours	Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.	Baseline
Primary	Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12	Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.	Baseline and Week 12
Secondary	Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4	Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.	Baseline and Week 4
Secondary	Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12	Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4 and 12
Secondary	Number of Nocturnal Micturitions Per 24 Hours	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.	Baseline
Secondary	Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.	Baseline, Week 4 and 12
Secondary	Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4 and 12
Secondary	Mean Number of Micturitions Per 24 Hours	Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12	Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline, Week 4 and 12
Secondary	Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4 and 12
Secondary	Number of Micturition-related Urgency Episodes Per 24 Hours	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline
Secondary	Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline, Week 4 and 12
Secondary	Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4 and 12
Secondary	Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline
Secondary	Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline, Week 4 and 12
Secondary	Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4 and 12
Secondary	Nocturnal Frequency-urgency Sum Rating Per 24 Hours	Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.	Baseline
Secondary	Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12	Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.	Baseline, Week 4 and 12
Secondary	Frequency-urgency Sum Rating Per 24 Hours	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.	Baseline
Secondary	Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.	Baseline, Week 4 and 12
Secondary	Mean Voided Volume Per Nocturnal Micturition	Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.	Baseline
Secondary	Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12	Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.	Baseline and Week 12
Secondary	Mean Voided Volume Per Micturition	Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.	Baseline
Secondary	Change From Baseline in Mean Voided Volume Per Micturition at Week 12	Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.	Baseline and Week 12
Secondary	Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.	Baseline
Secondary	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.	Baseline, Week 4 and 12
Secondary	Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Baseline
Secondary	Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Baseline, Week 4 and 12

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