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

• 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: Pfizer
• 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 ]

• 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

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

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