NCT00795509

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 374 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
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."

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-11-21
• Last updated: 2012-07-09
• Results posted: 2012-07-09