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Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder

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NCT01302938

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Mytrus, Inc.
San Francisco, California, 94104 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female and 21 years or older

- Overactive bladder symptoms (subject-reported) for at least 3 months

- Be resident in the United States of America and have access and be able to use a
computer with internet access throughout the duration of the study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically significant hepatic, renal or neurological condition such as stroke (with
residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.

- History of cystitis, continence, urogenitalcancer or radiation

- Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are
intending to become pregnant within 28 days after the completion of the trial.

NCT01302938
Pfizer
Terminated
Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder

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Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder
Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder
To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Tolterodine ER
    One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.
  • Drug: Placebo
    A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.
  • Experimental: Tolterodine ER
    Intervention: Drug: Tolterodine ER
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female and 21 years or older
  • Overactive bladder symptoms (subject-reported) for at least 3 months
  • Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study

Exclusion Criteria:

  • Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.
  • History of cystitis, continence, urogenitalcancer or radiation
  • Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.
Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01302938
A6121195
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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