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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658684
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : August 11, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Overactive Bladder
Intervention Drug: fesoterodine fumarate
Enrollment 153
Recruitment Details Subjects were screened at 12 centers in Japan.
Pre-assignment Details After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation.
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description All subjects Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Period Title: Overall Study
Started 152 99 25 28
Completed 133 84 22 27
Not Completed 19 15 3 1
Reason Not Completed
Adverse Event             10             8             2             0
Withdrawal by Subject             6             4             1             1
Lack of Efficacy             1             1             0             0
Protocol Violation             1             1             0             0
Pregnancy             1             1             0             0
Arm/Group Title 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg Total
Hide Arm/Group Description Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) Total of all reporting groups
Overall Number of Baseline Participants 99 25 28 152
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 25 participants 28 participants 152 participants
51.0  (13.1) 54.7  (10.5) 57.0  (11.7) 52.7  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 25 participants 28 participants 152 participants
Female
88
  88.9%
21
  84.0%
24
  85.7%
133
  87.5%
Male
11
  11.1%
4
  16.0%
4
  14.3%
19
  12.5%
1.Primary Outcome
Title Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
Hide Description The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 152 99 25 28
Measure Type: Number
Unit of Measure: Number of subjects
All-causality AEs 138 91 25 22
Treatment-related AEs 102 61 25 16
Serious AEs 1 1 0 0
Severe AEs 0 0 0 0
Discontinuations due to all-causlity AEs 10 8 2 0
Discontinuations due to treatment-related AEs 7 6 1 0
DR/TD due to all-causality AEs 30 6 23 1
DR/TD due to treatment-related AEs 23 0 23 0
2.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
Hide Description

The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Time Frame Week 4, 8, 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 101 60 17 24
Mean (Standard Deviation)
Unit of Measure: Number of episodes
Baseline (n=101, 60, 17, 24) 1.6  (1.48) 1.4  (1.23) 1.7  (1.24) 2.1  (2.04)
Week 4 (n=101, 60, 17, 24) -0.86  (1.104) -0.99  (1.117) -0.73  (1.281) -0.63  (0.918)
Week 8 (n=100, 59, 17, 24) -1.15  (1.293) -1.16  (1.173) -1.31  (1.450) -1.00  (1.491)
Week 28 (n=95, 56, 16, 23) -1.28  (1.282) -1.24  (1.185) -1.25  (1.518) -1.41  (1.385)
Week 52 (n= 92, 54, 15, 23) -1.34  (1.553) -1.23  (1.228) -1.18  (1.661) -1.71  (2.097)
Week 52 (LOCF) (n=101, 60, 17, 24) -1.35  (1.521) -1.19  (1.176) -1.22  (1.568) -1.82  (2.120)
3.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
Hide Description

The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Time Frame Week 4, 8, 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Mean (Standard Deviation)
Unit of Measure: Number of micturitions
Baseline (n=150, 97, 25, 28) 11.3  (2.85) 11.0  (2.69) 11.2  (2.71) 12.3  (3.31)
Week 4 (n=150, 97, 25, 28) -1.42  (1.855) -1.73  (1.899) -1.28  (1.403) -0.45  (1.757)
Week 8 (n=148, 95, 25, 28) -2.11  (1.946) -2.03  (1.897) -1.81  (2.035) -2.63  (2.005)
Week 28 (n=137, 87, 23, 27) -2.33  (2.338) -2.18  (2.351) -2.06  (2.260) -3.02  (2.315)
Week 52 (n=133, 84, 22, 27) -2.63  (2.220) -2.48  (2.02) -2.21  (2.196) -3.44  (2.683)
Week 52 (LOCF) (n=150, 97, 25, 28) -2.49  (2.172) -2.35  (1.970) -2.04  (2.135) -3.36  (2.673)
4.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
Hide Description

The 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.

The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Time Frame Week 4, 8, 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Mean (Standard Deviation)
Unit of Measure: Number of episodes
Baseline (n=150, 97, 25, 28) 4.5  (3.40) 3.9  (3.31) 6.2  (3.72) 5.1  (2.87)
Week 4 (n=150, 97, 25, 28) -1.69  (2.009) -1.77  (1.856) -1.75  (2.572) -1.37  (2.001)
Week 8 (n=148, 95, 25, 28) -2.44  (2.194) -2.32  (1.881) -2.59  (2.940) -2.70  (2.463)
Week 28 (n=137, 87, 23, 27) -2.54  (2.597) -2.41  (1.855) -3.12  (3.304) -2.46  (3.780)
Week 52 (n=133, 84, 22, 27) -2.76  (2.901) -2.55  (2.579) -2.80  (3.193) -3.37  (3.565)
Week 52 (LOCF) (n=150, 97, 25, 28) -2.61  (2.885) -2.30  (2.531) -2.93  (3.319) -3.40  (3.504)
5.Secondary Outcome
Title Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
Hide Description

The 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.

The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Time Frame Week 4, 8, 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 103 62 17 24
Mean (Standard Deviation)
Unit of Measure: Number of episodes
Baseilne (n=103, 62, 17,24) 1.8  (1.74) 1.6  (1.34) 1.8  (1.33) 2.5  (2.63)
Week 4 (n=103, 62, 17,24) -0.84  (1.140) -0.99  (1.166) -0.80  (1.225) -0.49  (0.963)
Week 8 (n=102, 61, 17, 24) -1.23  (1.354) -1.16  (1.272) -1.43  (1.504) -1.28  (1.486)
Week 28 (n= 97, 58, 16, 23) -1.39  (1.476) -1.26  (1.322) -1.31  (1.542) -1.77  (1.779)
Week 52 (n=94, 56, 15, 23) -1.37  (1.589) -1.26  (1.331) -1.16  (1.847) -1.75  (1.962)
Week 52 (LOCF) (n=103, 62, 17,24) -1.38  (1.557) -1.24  (1.282) -1.20  (1.740) -1.86  (1.990)
6.Secondary Outcome
Title Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
Hide Description

The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Time Frame Week 4, 8, 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 116 69 23 24
Mean (Standard Deviation)
Unit of Measure: Number of micturitions
Baseline (n=116, 69, 23, 24) 1.4  (1.04) 1.2  (1.04) 1.6  (0.93) 1.6  (1.05)
Week 4 (n=116, 69, 23, 24) -0.31  (0.727) -0.34  (0.752) -0.45  (0.556) -0.08  (0.776)
Week 8 (n=115, 68, 23, 24) -0.43  (0.797) -0.33  (0.812) -0.55  (0.845) -0.60  (0.688)
Week 28 (n=106, 62, 21, 23) -0.47  (0.752) -0.36  (0.788) -0.56  (0.694) -0.71  (0.661)
Week 52 (n=103, 60, 20, 23) -0.57  (0.807) -0.46  (0.904) -0.68  (0.546) -0.75  (0.698)
Week 52 (LOCF) (n=116, 69, 23, 24) -0.50  (0.826) -0.38  (0.908) -0.62  (0.614) -0.71  (0.718)
7.Secondary Outcome
Title Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
Hide Description

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.

The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.

Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline

Time Frame Week 4, 8, 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Mean (Standard Deviation)
Unit of Measure: mL
Baseline (n=150, 97, 25, 28) 158.1  (48.09) 162.8  (48.78) 156.1  (42.75) 143.6  (48.73)
Week 4 (n=150, 97, 25, 28) 16.67  (41.908) 20.58  (44.357) 12.18  (43.399) 7.16  (29.231)
Week 8 (n=148, 95, 25, 28) 22.34  (51.339) 21.86  (58.194) 23.00  (35.061) 23.37  (38.273)
Week 28 (n=137, 87, 23, 27) 32.59  (46.389) 31.98  (50.365) 40.20  (41.613) 28.10  (36.431)
Week 52 (n=133, 84, 22, 27) 35.92  (44.007) 40.21  (47.646) 33.02  (40.772) 24.95  (32.414)
Week 52 (LOCF) (n=150, 97, 25, 28) 33.42  (45.175) 37.08  (49.276) 28.22  (40.693) 25.38  (31.890)
8.Secondary Outcome
Title Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
Hide Description

KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.

KHQ consists of the following domains:

  • General health perceptions (GHP)
  • Impact on life
  • Role limitations
  • Physical limitations
  • Social limitations
  • Personal relationships (PR)
  • Emotions
  • Sleep/energy
  • Incontinence severity measures (ISM)

Change: mean at Week 28 and 52 minus mean at Baseline

Time Frame Week 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Mean (Standard Deviation)
Unit of Measure: Scores on a ascle
GHP: Baseline (n=150, 97, 25, 28) 37.5  (21.63) 37.1  (21.38) 37.0  (24.07) 39.3  (20.89)
GHP: Week 28 (n=137, 87, 23, 27) -2.19  (24.903) -0.57  (26.131) 0.00  (22.613) -9.26  (22.088)
GHP: Week 52 (n=134, 85, 22, 27) -5.22  (22.751) -5.88  (23.981) -5.68  (21.729) -2.78  (20.016)
Impact on life: Baseline (n=150, 97, 25, 28) 64.0  (23.97) 61.2  (21.88) 68.0  (31.15) 70.2  (22.84)
Impact on life: Week 28 (n=137, 87, 23, 27) -32.85  (27.112) -32.18  (24.084) -37.68  (33.791) -30.86  (30.559)
Impact on life: Week 52 (n=134, 85, 22, 27) -33.08  (29.333) -32.94  (26.970) -31.82  (33.297) -34.57  (33.945)
Role limitations: Baseline (n=150, 97, 25, 28) 47.9  (24.75) 46.0  (23.05) 52.0  (30.55) 50.6  (25.04)
Role limitations: Week 28 (n=137, 87, 23, 27) -28.10  (24.733) -28.16  (22.777) -33.33  (28.427) -23.46  (27.448)
Role limitations: Week 52 (n=134, 85, 22, 27) -29.85  (26.732) -30.98  (26.371) -31.06  (28.310) -25.31  (27.100)
Physical limitations: Baseline (n=150, 97, 25, 28 51.9  (26.93) 49.8  (26.73) 54.0  (29.38) 57.1  (25.43)
Physical limitations: Week 28 (n=137, 87, 23, 27) -27.25  (26.031) -26.63  (25.727) -31.16  (29.432) -25.93  (24.605)
Physical limitations: Week 52 (n=134, 85, 22, 27) -30.10  (25.071) -32.16  (24.504) -28.03  (25.915) -25.31  (26.300)
Social limitations: Baseline (n=150, 97, 25, 28) 30.3  (24.36) 27.5  (23.38) 31.1  (25.86) 39.3  (25.03)
Social limitations: Week 28 (n=137, 87, 23, 27) -19.63  (19.410) -17.37  (19.241) -22.71  (19.955) -24.28  (19.006)
Social limitations: Week 52 (n=134, 85, 22, 27) -22.35  (22.661) -20.72  (22.245) -24.75  (21.668) -25.51  (25.000)
PR: Baseline (n=124, 82, 18, 24) 19.5  (22.46) 17.3  (20.86) 16.7  (22.87) 29.2  (25.66)
PR: Week 28 (n=110, 71, 16, 23) -13.18  (18.354) -11.74  (18.558) -10.42  (17.078) -19.57  (17.875)
PR: Week 52 (n=109, 70, 16, 23) -14.68  (19.342) -13.57  (19.514) -12.50  (17.743) -19.57  (19.881)
Emotions: Baseline (n=150, 97, 25, 28) 51.2  (28.38) 49.1  (27.49) 52.0  (32.19) 57.5  (27.89)
Emotions: Week 28 (n=137, 87, 23, 27) -27.49  (24.219) -27.84  (23.163) -27.54  (26.137) -26.34  (26.714)
Emotions: Week 52 (n=134, 85, 22, 27) -30.27  (26.434) -32.42  (24.799) -26.26  (28.595) -26.75  (29.760)
Sleep/energy: Baseline (n=150, 97, 25, 28) 37.0  (27.44) 33.2  (24.00) 37.3  (29.77) 50.0  (33.02)
Sleep/energy: Week 28 (n=137, 87, 23, 27) -18.61  (21.586) -17.43  (19.998) -18.12  (26.070) -22.84  (22.715)
Sleep/energy: Week 52 (n=134, 85, 22, 27) -21.27  (23.338) -20.59  (22.219) -15.91  (22.700) -27.78  (26.554)
ISM: Baseline (n=150, 97, 25, 28) 34.8  (20.39) 32.6  (18.83) 31.5  (18.51) 45.7  (24.05)
ISM: Week 28 (n=137, 87, 23, 27) -16.25  (17.223) -14.87  (16.541) -16.81  (17.623) -20.25  (18.990)
ISM: Week 52 (n=134, 85, 22, 27) -19.00  (19.199) -18.43  (18.392) -14.55  (19.370) -24.44  (21.001)
9.Secondary Outcome
Title Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
Hide Description

OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).

Change: mean at Week 28 and 52 minus mean at baseline

Time Frame Week 28 and 52
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The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
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All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
SBS: Baseline (n=150, 97, 25, 28) 42.7  (22.53) 37.4  (19.74) 45.2  (21.04) 58.7  (25.55)
SBS: Week 28 (n=137, 87, 23, 27) -25.13  (19.835) -22.30  (18.588) -27.07  (16.231) -32.59  (24.578)
SBS: Week 52 (n=134, 85, 22, 27) -25.24  (20.287) -22.41  (17.616) -21.25  (16.597) -37.41  (26.206)
HRQL-Total: Baseline (n=150, 97, 25, 28) 70.7  (18.31) 73.9  (16.66) 72.2  (18.97) 58.4  (18.64)
HRQL-Total: Week 28 (n=137, 87, 23, 27) 15.66  (14.711) 14.26  (13.366) 16.00  (14.787) 19.88  (18.191)
HRQL-Total: Week 52 (n=134, 85, 22, 27) 16.92  (16.461) 15.99  (14.717) 13.35  (14.961) 22.76  (21.365)
HRQL-Coping: Baseline (n=150, 97, 25, 28) 61.6  (26.07) 65.6  (24.59) 64.6  (26.49) 45.1  (25.04)
HRQL-Coping: Week 28 (n=137, 87, 23, 27) 20.86  (20.008) 19.66  (17.871) 18.15  (18.605) 27.04  (26.339)
HRQL-Coping: Week 52 (n=134, 85, 22, 27) 21.75  (23.773) 20.91  (21.821) 15.00  (18.127) 29.91  (31.259)
HRQL-Concern: Baseline (n=150, 97, 25, 28) 71.0  (21.54) 73.9  (19.70) 72.5  (20.90) 59.5  (24.98)
HRQL-Concern: Week 28 (n=137, 87, 23, 27) 18.48  (18.180) 16.95  (17.142) 21.24  (17.943) 21.06  (21.515)
HRQL-Concern: Week 52 (n=134, 85, 22, 27) 19.77  (18.400) 19.23  (16.946) 16.49  (17.961) 24.13  (22.669)
HRQL-Sleep: Baseline (n=150, 97, 25, 28) 66.5  (23.95) 69.9  (22.30) 65.8  (25.61) 55.6  (25.45)
HRQL-Sleep: Week 28 (n=137, 87, 23, 27) 12.41  (21.808) 11.13  (21.579) 13.22  (19.313) 15.85  (24.769)
HRQL-Sleep: Week 52 (n=134, 85, 22, 27) 14.90  (21.467) 13.32  (19.629) 13.09  (19.873) 21.33  (27.197)
HRQL-Social: Baseline (n=150, 97, 25, 28) 89.2  (14.17) 91.2  (12.31) 90.6  (13.71) 81.0  (17.81)
HRQ- Social: Week 28 (n=137, 87, 23, 27) 6.66  (11.461) 5.01  (10.064) 8.00  (13.156) 10.81  (13.304)
HRQL-Social: Week 52 (n=134, 85, 22, 27) 7.22  (12.277) 6.26  (10.537) 6.55  (12.802) 10.81  (16.222)
10.Secondary Outcome
Title The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
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The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:

  1. no problems at all
  2. some very minor problems
  3. some minor problems
  4. some moderate problems
  5. severe problems
  6. many severe problems
Time Frame Week 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Measure Type: Number
Unit of Measure: Number of subjects
Week 28 (n=137, 87, 23, 27) 115 75 21 19
Week 52 (n=134, 85, 22, 27) 116 75 18 23
11.Secondary Outcome
Title Change From Baseline in Grade of PPBC at Week 28 and 52
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The PPBC assessment was rated on a 6-point scale as follows:

  1. no problems at all
  2. some very minor problems
  3. some minor problems
  4. some moderate problems
  5. severe problems
  6. many severe problems

Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.

Time Frame Week 28 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description:
All subjects
Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
Overall Number of Participants Analyzed 150 97 25 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline (n=150, 97, 25, 28) 4.3  (0.51) 4.2  (0.43) 4.5  (0.65) 4.4  (0.56)
Week 28 (n=137, 87, 23, 27) -1.66  (1.166) -1.74  (1.094) -1.83  (0.937) -1.26  (1.483)
Week 52 (n=134, 85, 22, 27) -1.78  (1.141) -1.85  (1.139) -1.59  (1.054) -1.70  (1.235)
Time Frame 52 Weeks
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Hide Arm/Group Description All subjects Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
All-Cause Mortality
Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/152 (0.66%)   1/99 (1.01%)   0/25 (0.00%)   0/28 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc disorder  1  1/152 (0.66%)  1/99 (1.01%)  0/25 (0.00%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Total 4 mg 4 mg > 8 mg > 4 mg 4 mg > 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   138/152 (90.79%)   91/99 (91.92%)   25/25 (100.00%)   22/28 (78.57%) 
Ear and labyrinth disorders         
Vertigo  1  3/152 (1.97%)  2/99 (2.02%)  0/25 (0.00%)  1/28 (3.57%) 
Eye disorders         
Vision blurred  1  3/152 (1.97%)  2/99 (2.02%)  1/25 (4.00%)  0/28 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper  1  5/152 (3.29%)  3/99 (3.03%)  1/25 (4.00%)  1/28 (3.57%) 
Constipation  1  20/152 (13.16%)  11/99 (11.11%)  7/25 (28.00%)  2/28 (7.14%) 
Diarrhoea  1  11/152 (7.24%)  5/99 (5.05%)  3/25 (12.00%)  3/28 (10.71%) 
Dry mouth  1  77/152 (50.66%)  43/99 (43.43%)  21/25 (84.00%)  13/28 (46.43%) 
Gastritis  1  9/152 (5.92%)  8/99 (8.08%)  1/25 (4.00%)  0/28 (0.00%) 
Nausea  1  4/152 (2.63%)  1/99 (1.01%)  2/25 (8.00%)  1/28 (3.57%) 
Periodontitis  1  3/152 (1.97%)  0/99 (0.00%)  1/25 (4.00%)  2/28 (7.14%) 
Stomatitis  1  4/152 (2.63%)  3/99 (3.03%)  0/25 (0.00%)  1/28 (3.57%) 
Infections and infestations         
Cystitis * 1  12/152 (7.89%)  8/99 (8.08%)  1/25 (4.00%)  3/28 (10.71%) 
Gastroenteritis  1  3/152 (1.97%)  3/99 (3.03%)  0/25 (0.00%)  0/28 (0.00%) 
Nasopharyngitis  1  50/152 (32.89%)  35/99 (35.35%)  7/25 (28.00%)  8/28 (28.57%) 
Upper respiratory tract infection  1  12/152 (7.89%)  8/99 (8.08%)  2/25 (8.00%)  2/28 (7.14%) 
Injury, poisoning and procedural complications         
Contusion  1  3/152 (1.97%)  1/99 (1.01%)  2/25 (8.00%)  0/28 (0.00%) 
Joint sprain  1  3/152 (1.97%)  3/99 (3.03%)  0/25 (0.00%)  0/28 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  4/152 (2.63%)  3/99 (3.03%)  1/25 (4.00%)  0/28 (0.00%) 
Aspartate aminotransferase increased  1  4/152 (2.63%)  3/99 (3.03%)  1/25 (4.00%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/152 (3.95%)  5/99 (5.05%)  1/25 (4.00%)  0/28 (0.00%) 
Back pain  1  16/152 (10.53%)  12/99 (12.12%)  1/25 (4.00%)  3/28 (10.71%) 
Nervous system disorders         
Dizziness  1  6/152 (3.95%)  3/99 (3.03%)  2/25 (8.00%)  1/28 (3.57%) 
Headache  1  5/152 (3.29%)  5/99 (5.05%)  0/25 (0.00%)  0/28 (0.00%) 
Somnolence  1  5/152 (3.29%)  1/99 (1.01%)  2/25 (8.00%)  2/28 (7.14%) 
Psychiatric disorders         
Insomnia  1  3/152 (1.97%)  2/99 (2.02%)  0/25 (0.00%)  1/28 (3.57%) 
Renal and urinary disorders         
Dysuria  1  6/152 (3.95%)  2/99 (2.02%)  3/25 (12.00%)  1/28 (3.57%) 
Residual urine  1  3/152 (1.97%)  1/99 (1.01%)  2/25 (8.00%)  0/28 (0.00%) 
Urine flow decreased  1  4/152 (2.63%)  1/99 (1.01%)  2/25 (8.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders         
Rhinitis allergic  1  7/152 (4.61%)  4/99 (4.04%)  1/25 (4.00%)  2/28 (7.14%) 
Skin and subcutaneous tissue disorders         
Eczema  1  4/152 (2.63%)  3/99 (3.03%)  0/25 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00658684     History of Changes
Other Study ID Numbers: A0221006
A0221006
First Submitted: April 9, 2008
First Posted: April 15, 2008
Results First Submitted: July 14, 2010
Results First Posted: August 11, 2010
Last Update Posted: October 13, 2010