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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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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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
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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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