Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00561951

First received: November 19, 2007

Last updated: July 11, 2011

Last verified: July 2011

History of Changes

Results First Received: January 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Overactive Bladder
Interventions:	Drug: fesoterodine fumarate Drug: Placebo

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.

Reporting Groups

	Description
Placebo	Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.

Participant Flow: Overall Study

	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
STARTED	318	320	313
COMPLETED	285	286	281
NOT COMPLETED	33	34	32
Adverse Event	11	14	14
Lack of Efficacy	5	3	2
Lost to Follow-up	1	1	0
Withdrawal by Subject	10	9	10
Protocol Violation	4	3	4
Physician Decision	1	0	0
Pregnancy	0	1	0
Meet Withdrawal Criterion	0	1	1
Adverse Event Occured Before Treatment	1	2	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg	Total
Number of Participants [units: participants]	318	320	313	951
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	227	217	196	640
>=65 years	91	103	117	311
Age [units: years] Mean ± Standard Deviation	56.7 ± 13.5	57.2 ± 14.2	58.8 ± 13.4	57.6 ± 13.7
Gender [units: participants]
Female	251	251	255	757
Male	67	69	58	194

Outcome Measures

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1. Primary:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]

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2. Secondary:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

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3. Secondary:

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]

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4. Secondary:

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

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5. Secondary:

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]

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6. Secondary:

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

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7. Secondary:

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]

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8. Secondary:

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

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9. Secondary:

Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. [ Time Frame: Baseline to Week 12 ]

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10. Secondary:

Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

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11. Secondary:

Change From Baseline in Mean Voided Volume Per Micturition at Week 12. [ Time Frame: Baseline to Week 12 ]

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12. Secondary:

Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Measure 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. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12
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.
Full analysis set. No imputation was used for missing data.

Reporting Groups

	Description
Placebo	Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.

Measured Values

	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Number of Participants Analyzed [units: participants]	309	314	306
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. [units: mL] Mean ± Standard Deviation
Week 2 (n=308, 314, 304)	5.06 ± 37.875	13.63 ± 35.350	21.52 ± 42.946
Week 4 (n=301, 303, 296)	9.23 ± 43.639	21.62 ± 44.623	27.41 ± 45.803
Week 8 (n=289, 289, 287)	10.75 ± 45.628	22.05 ± 44.949	30.94 ± 51.258
Week 12 (n=284, 284, 281)	13.28 ± 46.317	24.52 ± 48.620	33.40 ± 53.379

No statistical analysis provided for Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.

13. Secondary:

Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). [ Time Frame: Baseline to Week12 ]

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14. Secondary:

Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. [ Time Frame: Baseline to Week 12 ]

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15. Secondary:

Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Baseline to Week 12 ]

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16. Secondary:

The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12. [ Time Frame: Baseline to Week 12 ]

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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 < 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.

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.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00561951 History of Changes
Other Study ID Numbers:	A0221005
Study First Received:	November 19, 2007
Results First Received:	January 11, 2010
Last Updated:	July 11, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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