Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00611026

Purpose

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Condition	Intervention	Phase
Overactive Bladder	Drug: Tolterodine ER Drug: Placebo Drug: Fesoterodine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Tolterodine Tolterodine tartrate Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Secondary Outcome Measures:

Change From Baseline in Mean Voided Volume Per Micturition [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Change From Baseline in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Percent Change From Baseline of Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
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 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
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 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 [ Time Frame: Baseline, Week 1, Week 4 ] [ Designated as safety issue: No ]
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Percent Change From Baseline of UUI Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is

1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary [ Time Frame: Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Patient Perception of Bladder Condition (PPBC) [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ] [ Designated as safety issue: No ]
Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol. [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ] [ Designated as safety issue: No ]
Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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. Negative change in Symptom Bother Score indicates improvement.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
HRQL domain and total raw score derived as sum of scores (6-point scale:

1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.

Enrollment:	2417
Study Start Date:	February 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Tolterodine ER The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
Placebo Comparator: 2	Drug: Placebo Placebo treatment will be once daily(QD) for 12 weeks.
Experimental: 3	Drug: Fesoterodine The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00611026 History of Changes
Other Study ID Numbers:	A0221046
Study First Received:	January 28, 2008
Results First Received:	October 12, 2010
Last Updated:	January 28, 2011
Health Authority:	United States: Food and Drug Administration