Clinical trial NCT01488578: Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Official title: Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Japanese
Tolterodine
Detrusitol
Detrol
Postmarketing commitment plan.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 11157
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (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 subjects 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.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.

Exclusion Criteria:

* Subjects who have been prescribed Detrusitol Capsule before.

Primary outcomes:
measure: Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
timeFrame: 12 weeks
measure: Number of Participants Which Was Evaluated as "Degree of Satisfaction".
timeFrame: 12 week
measure: Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.
timeFrame: 12 week
measure: Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.
timeFrame: 12 week
Secondary outcomes:
measure: Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Gender
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Complications
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Age
timeFrame: 12 week
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy
timeFrame: 12 week
measure: Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day
timeFrame: 12 week
measure: Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment
timeFrame: 12 week
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: