A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Standardization of Fluid Intake on the Variability of Measured Voiding Parameters in Female Patients With Idiopathic Overactive Bladder

GlaxoSmithKline1 site in 1 country55 target enrollmentAugust 2007

ConditionsOveractive Bladder

DrugsDETROL LA (drug)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: GlaxoSmithKline
Enrollment: 55
Locations: 1
Primary Endpoint: Variability of change from baseline in mean volume per void measured on 3 consecutive days.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for Overactive Bladder.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

January 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period.
•Eligible patients must have signed the informed consent and must meet all inclusion and exclusion criteria as determined during the screening visit.

Exclusion Criteria

•Any abnormality identified on the screening examination or any other medical condition or circumstance making the patient unsuitable for participation in the study based on the Investigator's and Medical Monitor's assessment
•Any contraindication to Detrol LA or other anti-muscarinic medications
•Inability to consume 10 cc/kg of fluid within 30 minutes
•Regular alcohol consumption averaging ³7 drinks/week for women (1 drink = 100mL of wine or 285mL of beer or 30mL of hard liquor)
•Positive urine drug or alcohol at screening at screening
•Average blood pressure measurements systolic ≥140 or diastolic ≥90 at screening at screening
•QTcB value ≥ 450 msec at screening
•Poorly-controlled diabetes mellitus or hypertension, as evidenced by a change in medication within the 2 months prior to initiation of the study
•History of urinary retention or gastric retention
•Known history of narrow-angle glaucoma

Outcomes

Primary Outcomes

Variability of change from baseline in mean volume per void measured on 3 consecutive days.

Time Frame: 3 consecutive days

Secondary Outcomes

Mean change from baseline in volume voided per void. Percent and actual change from baseline in maximum volume voided, number of micturitions, number of incontinence episodes, number of urgency episodes, and time to first void on 3 consecutive days.(3 consecutive days)