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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00658684

First received: April 9, 2008

Last updated: October 5, 2010

Last verified: October 2010

History of Changes

Results First Received: July 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Overactive Bladder
Intervention:	Drug: fesoterodine fumarate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened at 12 centers in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Total	All subjects
4 mg	Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
4 mg > 8 mg > 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)
4 mg > 8 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)

Participant Flow: Overall Study

	Total	4 mg	4 mg > 8 mg > 4 mg	4 mg > 8 mg
STARTED	152	99	25	28
COMPLETED	133	84	22	27
NOT COMPLETED	19	15	3	1
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

Baseline Characteristics

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Reporting Groups

	Description
4 mg	Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
4 mg > 8 mg > 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)
4 mg > 8 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	Total of all reporting groups

Baseline Measures

	4 mg	4 mg > 8 mg > 4 mg	4 mg > 8 mg	Total
Number of Participants [units: participants]	99	25	28	152
Age [units: years] Mean ± Standard Deviation	51.0 ± 13.1	54.7 ± 10.5	57.0 ± 11.7	52.7 ± 12.6
Gender [units: Number of subjects]
Female	88	21	24	133
Male	11	4	4	19

Outcome Measures

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1. Primary:

Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume [ Time Frame: 52 Weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

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3. Secondary:

Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

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5. Secondary:

Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

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6. Secondary:

Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

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7. Secondary:

Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 [ Time Frame: Week 4, 8, 28 and 52 ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 [ Time Frame: Week 28 and 52 ]

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9. Secondary:

Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 [ Time Frame: Week 28 and 52 ]

Show Outcome Measure 9

10. Secondary:

The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage [ Time Frame: Week 28 and 52 ]

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Measure Type	Secondary
Measure 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
Measure Description	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: no problems at all some very minor problems some minor problems some moderate problems severe problems many severe problems
Time Frame	Week 28 and 52
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Total	All subjects
4 mg	Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
4 mg > 8 mg > 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)
4 mg > 8 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)

Measured Values

	Total	4 mg	4 mg > 8 mg > 4 mg	4 mg > 8 mg
Number of Participants Analyzed [units: participants]	150	97	25	28
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage [units: 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

No statistical analysis provided for The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage

11. Secondary:

Change From Baseline in Grade of PPBC at Week 28 and 52 [ Time Frame: Week 28 and 52 ]

Show Outcome Measure 11

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00658684 History of Changes
Other Study ID Numbers:	A0221006, A0221006
Study First Received:	April 9, 2008
Results First Received:	July 14, 2010
Last Updated:	October 5, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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