Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

This study has been terminated.
(Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00832650
First received: January 28, 2009
Last updated: December 2, 2010
Last verified: December 2010
Results First Received: December 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: fesoterodine fumarate
Drug: placebo
Drug: solifenacin

  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
No text entered.

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 8 mg tablet once daily
Placebo Matched placebo tablet or capsule
Solifenacin Solifenacin 10 mg capsule once daily

Participant Flow:   Overall Study
    Fesoterodine     Placebo     Solifenacin  
STARTED     25     12     23  
Treated     25     12     22  
COMPLETED     25     12     22  
NOT COMPLETED     0     0     1  
Randomized but not treated                 0                 0                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Fesoterodine Fesoterodine 8 mg tablet once daily
Placebo Matched placebo tablet or capsule
Solifenacin Solifenacin 10 mg capsule once daily
Total Total of all reporting groups

Baseline Measures
    Fesoterodine     Placebo     Solifenacin     Total  
Number of Participants  
[units: participants]
  25     12     23     60  
Age, Customized  
[units: participants]
       
less than 18 years     0     0     0     0  
18 to 25 years     5     5     6     16  
26 to 35 years     7     2     6     15  
36 to 45 years     7     2     8     17  
greater than 45 years     6     3     3     12  
Gender  
[units: participants]
       
Female     25     12     23     60  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Colonic Transit at 24 Hours   [ Time Frame: Day 13 (Day 12 24 hours post-meal) ]

2.  Secondary:   Proximal Colonic Emptying Time   [ Time Frame: Day 12 to 14 ]

3.  Secondary:   Colonic Transit at 48 Hours   [ Time Frame: Day 14 (Day 12 48 hours post-meal) ]

4.  Secondary:   Colonic Filling at 6 Hours   [ Time Frame: Day 12 ]

5.  Secondary:   Time to Gastric Emptying   [ Time Frame: Day 12: 2 hours, 4 hours ]

6.  Secondary:   Mean Number of Stools Per Day   [ Time Frame: Day 11 to 13 ]

7.  Secondary:   Mean Score of Stool Consistency Per Day   [ Time Frame: Day 11 to 13 ]

8.  Secondary:   Average Score of Ease of Passage During Defecation Per Day   [ Time Frame: Day 11 to 13 ]

9.  Secondary:   Mean Proportion of Bowel Movements With Satisfaction Per Day   [ Time Frame: Day 11 to 13 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Study was terminated due to futility based on interim analysis with 60 subjects. Although the results of statistical test for the primary endpoint was interpreted, the other endpoint results were interpreted based on statistical inference.


  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:
unchecked 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.
unchecked 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.


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 by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00832650     History of Changes
Obsolete Identifiers: NCT00892034
Other Study ID Numbers: A0221057
Study First Received: January 28, 2009
Results First Received: December 2, 2010
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration