Fesoterodine Flexible Dose Study

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00536484

First received: September 25, 2007

Last updated: September 10, 2009

Last verified: September 2009

History of Changes

Results First Received: March 12, 2009

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 Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were screened at 90 centers in the United States; in 88 centers, participants were randomized.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 2-week no-treatment screening period and a 12-week double-blind treatment period. Participants with bothersome overactive bladder (OAB) symptoms who met all entry criteria at baseline (end of screening) were randomized.

Reporting Groups

	Description
Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Participant Flow: Overall Study

	Placebo	Fesoterodine
STARTED	445 ^[1]	438 ^[2]
COMPLETED	385 ^[3]	382 ^[4]
NOT COMPLETED	60	56
Adverse Event	21	34
Withdrawal by Subject	11	11
Lost to Follow-up	8	6
Lack of Efficacy	16	5
unknown	4	0

[1]	448 participants randomised; 3 not treated
[2]	448 participants randomised; 10 not treated
[3]	88 completed on matched 4mg dose and 297 on matched 8mg dose
[4]	134 completed on 4mg dose and 248 on 8mg dose

Baseline Characteristics

Show Baseline Characteristics

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2 and Week 6 ]

Show Outcome Measure 2

3. Secondary:

Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 3

4. Secondary:

Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 4

5. Secondary:

Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 5

6. Secondary:

Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 6

7. Secondary:

Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 7

8. Secondary:

Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 8

9. Secondary:

Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale [ Time Frame: Baseline and Week 12 ]

Show Outcome Measure 9

10. Secondary:

Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales [ Time Frame: Baseline and Week 12 ]

Show Outcome Measure 10

11. Secondary:

Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 11

12. Secondary:

Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 12

13. Secondary:

Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline [ Time Frame: Baseline, Week 2, Week 6 and Week 12 ]

Show Outcome Measure 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:	NCT00536484 History of Changes
Other Study ID Numbers:	A0221014
Study First Received:	September 25, 2007
Results First Received:	March 12, 2009
Last Updated:	September 10, 2009
Health Authority:	United States: Food and Drug Administration

To Top