Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
NCT01488578
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Subjects who have been prescribed Detrusitol Capsule before.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) | |||
| Official Title | Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting | |||
| 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. | |||
| 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 subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule). | |||
| Condition | Overactive Bladder | |||
| Intervention | Drug: Tolterodine tartrate
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows. Other Name: Detrusitol Capsule,Tolterodine tartrate. | |||
| Study Groups/Cohorts | Tolterodine tartrate.
Subjects 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 | 11157 | |||
| Original Actual Enrollment | Same as current | |||
| Actual Study Completion Date | March 2011 | |||
| Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 | NCT01488578 | |||
| Other Study ID Numbers | A6121186 | |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2012 | |||