Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01054222

First received: January 20, 2010

Last updated: April 2, 2013

Last verified: February 2013

History of Changes

Results First Received: December 17, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Urinary Bladder, Overactive
Intervention:	Drug: Fesoterodine

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 who completed treatment in study A0221045 (NCT00798434) were included in this study as per investigator's discretion.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Fesoterodine	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).

Participant Flow: Overall Study

	Fesoterodine
STARTED	31
COMPLETED	20
NOT COMPLETED	11
Lack of Efficacy	1
Lost to Follow-up	4
Withdrawal by Subject	6

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Fesoterodine	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).

Baseline Measures

	Fesoterodine
Number of Participants [units: participants]	31
Age [units: Years] Mean ± Standard Deviation	75.4 ± 6.0
Gender [units: Participants]
Female	30
Male	1

Outcome Measures

Show All Outcome Measures

1. Primary:

Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT]) [ Time Frame: End of Treatment (up to Week 82) ]

Show Outcome Measure 1

2. Secondary:

Mean Number of Micturition-Related Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18 ]

Show Outcome Measure 2

3. Secondary:

Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 3

4. Secondary:

Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 4

5. Secondary:

Mean Number of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 5

6. Secondary:

Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 6

7. Secondary:

Daily Sum Rating on the Urinary Sensation Scale (USS) [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 7

8. Secondary:

Percentage of Incontinent Participants at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 8

9. Secondary:

Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode [ Time Frame: Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 9

10. Secondary:

Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 10

11. Secondary:

Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 11

12. Secondary:

Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 12

13. Secondary:

Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 13

14. Secondary:

Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ]

Show Outcome Measure 14

15. Secondary:

Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b) [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82) ]

Show Outcome Measure 15

16. Secondary:

King’s Health Questionnaire (KHQ) Domain Scores [ Time Frame: Baseline, End of Treatment (EOT) (Week 82) ]

Show Outcome Measure 16

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 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
Due to the small sample size and that this is a single country study (Portugal) the results should be interpreted with caution.

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:	Pfizer
ClinicalTrials.gov Identifier:	NCT01054222 History of Changes
Other Study ID Numbers:	A0221090
Study First Received:	January 20, 2010
Results First Received:	December 17, 2012
Last Updated:	April 2, 2013
Health Authority:	United States: Food and Drug Administration

To Top