NCT00139724

Brief Summary

To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Geographic Reach
1 country

7 active sites

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

August 29, 2005

Last Update Submit

January 26, 2021

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder

Secondary Outcomes (1)

  • To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder.

Interventions

tolterodine extended release capsuleDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a diagnosis of overactive bladder.

You may not qualify if:

  • Subjects with significant stress incontinence as determined by the investigator.
  • Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Beijing, Beijing Municipality, 100020, China

Location

Pfizer Investigational Site

Beijing, Beijing Municipality, 100034, China

Location

Pfizer Investigational Site

Huangzhou, Zhejiang, 310003, China

Location

Pfizer Investigational Site

Beijing, 100034, China

Location

Pfizer Investigational Site

Chongqing, China

Location

Pfizer Investigational Site

Shanghai, 200040, China

Location

Pfizer Investigational Site

Shanghai, 200127, China

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

CN(7)