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A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00768521
First received: October 7, 2008
Last updated: August 1, 2014
Last verified: August 2014
Results First Received: August 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Drug: tolterodine tartrate
Drug: Comparator: Placebo to tolterodine tartrate

  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

First Patient Entered: 8 Sep 2008

Last Patient, Last Visit: 19 Jan 2009

2 sites Since Part I of the study enrolled sufficiently there was no need to modify the study design nor conduct Part II.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients completed a 1-week screening and 1-week placebo run-in period.

Patients were randomized Visit 3/Day 1. Patients were excluded if they were unable to adequately complete a diary, number of micturitions was ≤ 8, or number of urge incontinence was ≤ 1 on each diary day.


Reporting Groups
  Description
Tolterodine Then Placebo Tolterodine 4 mg then Placebo
Placebo Then Tolterodine Placebo then Tolterodine 4 mg

Participant Flow for 2 periods

Period 1:   Period 1
    Tolterodine Then Placebo     Placebo Then Tolterodine  
STARTED     9     11  
COMPLETED     9     11  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Tolterodine Then Placebo     Placebo Then Tolterodine  
STARTED     9     11  
COMPLETED     9     11  
NOT COMPLETED     0     0  



  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
All Participants All Study Participants from all groups.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean ( Full Range )
  59.1  
  ( 45 to 70 )  
Gender  
[units: participants]
 
Female     20  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo   [ Time Frame: 4 hours post dose 7 ]

2.  Secondary:   Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo   [ Time Frame: 4 hours post dose 1 ]


  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
The analysis presented includes all patients. An analysis excluding patients who were misdosed yielded different results with a similar conclusion and are not presented.


  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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00768521     History of Changes
Other Study ID Numbers: 0000-107, 2008_560
Study First Received: October 7, 2008
Results First Received: August 1, 2014
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board