Clinical trial NCT01302938: Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Double-blind
Placebo-controlled
frequency
urgency
web-based
incontinence
methodology
ediary
safety
efficacy
tolerability ER
overactive bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 18
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12
timeFrame: Baseline, Week 1, 4, 12
measure: Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12
timeFrame: Baseline, Week 1, 4, 12
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4
timeFrame: Baseline, Week 1, 4
measure: Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12
timeFrame: Baseline, Week 1, 4, 12
measure: Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
timeFrame: Baseline, Week 1, 4, 12
measure: Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
timeFrame: Baseline, Week 1, 4, 12
measure: Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12
timeFrame: Baseline, Week 1, 4, 12
measure: Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12
timeFrame: Baseline (Bl), Week 1, 4, 12
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Response Regarding Source of First Information About Study
timeFrame: Week 12
measure: Number of Participants With Reason for Participation in the Study
timeFrame: Week 12
measure: Participant Perception Regarding Satisfaction Related to Study
timeFrame: Week 12
measure: Participant Perception Regarding Cell Phone Diary
timeFrame: Week 12
measure: Participant Perception Regarding Received Treatment in the Study
timeFrame: Week 12
measure: Participant Perception Regarding Recommending a Friend to Enter Similar Study
timeFrame: Week 12
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Adverse Events (AEs) by Relatedness and Severity
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants Who Discontinued the Study Due to Adverse Events
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Week 12
Locations:
city: San Francisco
country: United States
facility: Mytrus, Inc.
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.