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Trial record 1 of 1 for:    NCT00691093
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Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

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ClinicalTrials.gov Identifier: NCT00691093
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : November 18, 2010
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Overactive Bladder
Urinary Incontinence
Intervention Drug: fesoterodine
Enrollment 823
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fesoterodine 4 mg or 8 mg
Hide Arm/Group Description The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Period Title: Overall Study
Started 823
Completed 816
Not Completed 7
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Lack of Efficacy             1
Ongoing at Date of Cut-Off             4
Arm/Group Title Fesoterodine 4 mg
Hide Arm/Group Description The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Overall Number of Baseline Participants 823
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 823 participants
<18 years 11
18-44 years 102
44-64 497
>=65 years 213
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 823 participants
Female
574
  69.7%
Male
249
  30.3%
1.Primary Outcome
Title Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
Hide Description Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.
Time Frame Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
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Hide Analysis Population Description
The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: episodes
Baseline 11.661  (2.8565) 10.636  (3.4269) 12.664  (2.7612)
Visit 2 (Month 1) -2.306  (1.5773) -2.303  (1.2863) -1.566  (1.4241)
Visit 3 (Month 2) -3.482  (1.9022) -2.848  (1.1772) -3.160  (1.7571)
Visit 4 (Month 3 or ET) -4.180  (2.1018) -4.000  (1.2293) -4.031  (1.8995)
2.Primary Outcome
Title Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
Hide Description Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.
Time Frame Baseline, Month 1, Month 2, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: episodes
Baseline 3.027  (1.2593) 4.000  (1.4220) 3.528  (1.3452)
Visit 2 (Month 1) -1.104  (0.7960) -1.212  (0.8065) -0.915  (0.9115)
Visit 3 (Month 2) -1.621  (0.9281) -1.848  (1.1290) -1.613  (1.0928)
Visit 4 (Month 3 or ET) -1.914  (1.0820) -2.030  (1.3035) -2.072  (1.0907)
3.Primary Outcome
Title Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
Hide Description UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).
Time Frame Baseline, Month 1, Month 2, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: episodes
Baseline 4.412  (2.4355) 4.697  (1.9914) 5.587  (3.7759)
Visit 2 (Month 1) -1.890  (1.5967) -1.697  (0.9827) -1.650  (1.3065)
Visit 3 (Month 2) -2.736  (1.9249) -2.182  (1.4557) -2.895  (2.6468)
Visit 4 (Month 3 or ET) -3.127  (2.0210) -2.636  (1.7221) -3.814  (3.0690)
4.Primary Outcome
Title Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
Hide Description The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Time Frame Baseline, Month 1, Month 2, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: episodes
Baseline 2.601  (1.7127) 2.933  (1.2551) 3.467  (2.4484)
Visit 2 (Month 1) -1.209  (1.0891) -1.067  (1.1738) -1.190  (1.2532)
Visit 3 (Month 2) -1.806  (1.3107) -1.583  (1.4974) -1.781  (1.4729)
Visit 4 (Month 3 or ET) -2.065  (1.4582) -1.733  (1.6836) -2.362  (1.6477)
5.Secondary Outcome
Title Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
Hide Description The PVR urine volume: measured by an ultrasound scan.
Time Frame Baseline, Month 1, Month 2, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: ml
Baseline 27.932  (27.6079) 42.000  (35.6059) 24.867  (27.7108)
Visit 2 (Month 1) -6.650  (16.4784) -12.800  (13.2313) -2.364  (11.2500)
Visit 3 (Month 2) -9.864  (20.2348) -18.700  (22.2663) -5.791  (17.8493)
Visit 4 (Month 3 or ET) -12.800  (23.9575) -21.000  (24.3584) -7.415  (21.7658)
6.Secondary Outcome
Title Patient's Global Evaluation of Fesoterodine
Hide Description The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.
Time Frame Baseline, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.
Arm/Group Title All Subjects
Hide Arm/Group Description:
Fesoterodine 4 or 8 mg
Overall Number of Participants Analyzed 823
Measure Type: Number
Unit of Measure: participants
Excellent 536
Good 252
Fair 22
Poor 10
Missing 3
7.Secondary Outcome
Title Clinical Global Evaluation of Fesoterodine
Hide Description Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'
Time Frame 12 weeks
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Hide Analysis Population Description
SAS
Arm/Group Title All Subjects
Hide Arm/Group Description:
The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Overall Number of Participants Analyzed 823
Measure Type: Number
Unit of Measure: participants
Excellent 513
Good 274
Fair 24
Poor 9
Missing 3
8.Secondary Outcome
Title Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
Hide Description Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.
Time Frame Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.661  (1.1663) 5.818  (0.9816) 4.702  (1.7925)
9.Secondary Outcome
Title Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
Hide Description Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Time Frame Baseline, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 59.263  (17.5239) 70.000  (10.1242) 64.737  (17.1696)
Visit 4 (Month 3 or ET) 25.147  (14.3690) 35.682  (12.7520) 32.719  (17.9115)
10.Secondary Outcome
Title Change From Baseline in Total Scores of OAB-q at Visit 4
Hide Description Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Time Frame Baseline, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-34.101  (16.0799) -34.318  (9.4928) -32.018  (17.7183)
11.Secondary Outcome
Title Time To Onset Of Treatment Response
Hide Description Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
Time Frame Month 1, Month 2, Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Fesoterodine 4 mg Fesoterodine 8 mg Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 754 11 57
Median (Full Range)
Unit of Measure: weeks
3.0
(0 to 10)
3.0
(1 to 4)
3.0
(1 to 13)
12.Secondary Outcome
Title Study Doses
Hide Description Number of subjects that changed doses throughout the study period.
Time Frame Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title All Subjects
Hide Arm/Group Description:
Fesoterodine 4 or 8 mg
Overall Number of Participants Analyzed 823
Measure Type: Number
Unit of Measure: participants
Increased 57
Stayed the same 766
Decreased 0
Fluctuated 0
13.Secondary Outcome
Title Reasons for Study Treatment Dose Changes
Hide Description Possible change in the dose and the reasons for the change were collected and documented.
Time Frame Month 3 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title All Subjects
Hide Arm/Group Description:
Fesoterodine 4 mg or 8 mg
Overall Number of Participants Analyzed 823
Measure Type: Number
Unit of Measure: participants
Inefectivity, Not Sufficient Effectivity 22
Infectivity 29
Insufficient (efficiency) effect 1
Insufficient response 1
Poor overall response 1
Missing 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fesoterodine 4 mg or 8 mg
Hide Arm/Group Description All Subjects
All-Cause Mortality
Fesoterodine 4 mg or 8 mg
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Fesoterodine 4 mg or 8 mg
Affected / at Risk (%)
Total   0/823 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fesoterodine 4 mg or 8 mg
Affected / at Risk (%)
Total   78/823 (9.48%) 
Gastrointestinal disorders   
Constipation  1  11/823 (1.34%) 
Dry mouth  1  66/823 (8.02%) 
Gastrointestinal disorder  1  1/823 (0.12%) 
General disorders   
Adverse event  1  2/823 (0.24%) 
Nervous system disorders   
Headache  1  1/823 (0.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00691093    
Other Study ID Numbers: A0221059
First Submitted: June 3, 2008
First Posted: June 5, 2008
Results First Submitted: March 15, 2010
Results First Posted: November 18, 2010
Last Update Posted: November 2, 2018