A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

NCT00768521 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-22

Study results available
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Summary

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

Conditions

Interventions

DRUG

tolterodine tartrate

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule

DRUG

Comparator: Placebo to tolterodine tartrate

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-03
Primary Completion
2009-01-19
Completion
2009-01-19

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00768521 on ClinicalTrials.gov