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

NCT01302938 | Terminated Phase 4 Results

• 1 other identifier: A6121195
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Conditions

Overactive Bladder

Keywords

Double-blind; Placebo-controlled; frequency; urgency; web-based; incontinence; methodology; ediary; safety; efficacy; tolerability ER; overactive bladder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12

  Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.

  Baseline, Week 12

Secondary Outcomes (17)

• Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12

  Baseline, Week 1, 4, 12

• Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12

  Baseline, Week 1, 4, 12

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4

  Baseline, Week 1, 4

• Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12

  Baseline, Week 1, 4, 12

• Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12

  Baseline, Week 1, 4, 12

Other Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose

• Number of Participants With Adverse Events (AEs) by Relatedness and Severity

  Baseline up to 28 days after last dose

• Number of Participants Who Discontinued the Study Due to Adverse Events

  Baseline up to 28 days after last dose

Study Arms (2)

Tolterodine ER

EXPERIMENTAL

Drug: Tolterodine ER

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tolterodine ER DRUG

One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.

Tolterodine ER

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (2)

Mytrus, Inc.

San Francisco, California, 94104, United States

Location

University of California San Francisco

San Francisco, California, 94121, United States

Location

Related Publications (2)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

• 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.

  PMID: 24792229 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Limitations and Caveats

The study was terminated prematurely due to low participant enrollment and due to relatively small sample size; results should be interpreted with caution. Early termination of the study was not related to any safety concern.

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: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 24, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: September 24, 2013

Record last verified: 2021-01

Locations

US (2)