NCT01488578

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,157

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 14, 2012

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

4.2 years

First QC Date

April 27, 2011

Results QC Date

March 8, 2012

Last Update Submit

January 26, 2021

Conditions

Overactive Bladder

Keywords

Overactive BladderJapaneseTolterodineDetrusitolDetrolPostmarketing commitment plan.

Outcome Measures

Primary Outcomes (4)

  • Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).

    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.

    12 weeks

  • Number of Participants Which Was Evaluated as "Degree of Satisfaction".

    Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.

    12 week

  • Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.

    Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.

    12 week

  • Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.

    The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.

    12 week

Secondary Outcomes (12)

  • Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs

    12 week

  • Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies

    12 week

  • Risk Factors for the Proportion of Responders of Tolterodine-Gender

    12 week

  • Risk Factors for the Proportion of Responders of Tolterodine-Complications

    12 week

  • Risk Factors for the Proportion of Responders of Tolterodine-Age

    12 week

  • +7 more secondary outcomes

Study Arms (1)

Tolterodine tartrate.

Subjects taking Tolterodine tartrate.

Drug: Tolterodine tartrate

Interventions

Tolterodine tartrateDRUG

Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.

Also known as: Detrusitol Capsule,Tolterodine tartrate.
Tolterodine tartrate.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).

You may qualify if:

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

You may not qualify if:

  • Subjects who have been prescribed Detrusitol Capsule before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2011

First Posted

December 8, 2011

Study Start

December 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 28, 2021

Results First Posted

June 14, 2012

Record last verified: 2021-01