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Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795509
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : July 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 19, 2008
First Posted Date November 21, 2008
Results First Submitted Date March 7, 2012
Results First Posted Date July 9, 2012
Last Update Posted Date July 9, 2012
Study Start Date August 2007
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2012)
  • Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). [ Time Frame: 52 weeks ]
    All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
  • Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). [ Time Frame: 52 weeks ]
    All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Original Primary Outcome Measures
 (submitted: November 19, 2008)
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 52 weeks ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 52 weeks ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 52 weeks ]
Change History Complete list of historical versions of study NCT00795509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
Official Title Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).
Brief Summary The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed Description All the patients whom an investigator prescribes the first Detrusitol® Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).
Condition Urinary Bladder, Overactive
Intervention Drug: Tolterodine tartrate
Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability."
Other Name: Detrusitol® Capsule.
Study Groups/Cohorts Tolterodine tartrate.
Patients taking Tolterodine tartrate.
Intervention: Drug: Tolterodine tartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2012)
374
Original Estimated Enrollment
 (submitted: November 19, 2008)
100
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Detrusitol® Capsule.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00795509
Other Study ID Numbers A6121187
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2012