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

NCT01302938

Last updated date
Study Location
Mytrus, Inc.
San Francisco, California, 94104, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Tolterodine ER
    Intervention: Drug: Tolterodine ER
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Orri M, Lipset CH, Jacobs BP, Costello AJ, Cummings SR. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial. Contemp Clin Trials. 2014 Jul;38(2):190-7. doi: 10.1016/j.cct.2014.04.009. Epub 2014 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 30, 2012)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2011)
600
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01302938
Other Study ID Numbers  ICMJE A6121195
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP