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

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: Tolterodine tartrate

• Registration Number: NCT00795509
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-21
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-03-07
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Results First Posted: 2012-07-09
• Last Update Posted: 2012-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

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

Exclusion Criteria

• Patients not administered Detrusitol® Capsule.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tolterodine tartrate.	Tolterodine tartrate	Patients taking Tolterodine tartrate.

Primary Outcome Measures

Name	Time	Method
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).	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).	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.