The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive Bladder - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 2, 2007

Last Updated Date

October 9, 2008

Start Date ^†

August 2007

Current Primary Outcome Measures ^†

Variability of change from baseline in mean volume per void measured on 3 consecutive days. [ Time Frame: 3 consecutive days ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00553657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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. [ Time Frame: 3 consecutive days ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive Bladder

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study

Condition ^†

Overactive Bladder

Intervention ^†

Drug: DETROL LA (drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

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
History of QT prolongation
Known reduction in hepatic or renal function
Concomitant Use of loop diuretics (eg. Furosemide)
Concomitant use of a medication that is a potent inhibitor of CYP3A4
Class IA or Class III antiarrhythmic medications
Patient is unable and/or unwilling to adhere to Lifestyle Guidelines
For women of child bearing potential, a positive serum β-hCG at screening or pre-dose, or an unwillingness to agree to adequate contraception from the time of screening until the completion of the study:
Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening.
Presence of urinary tract infection within 4 weeks of screening.
Post-void residual of >150 mL (bladder ultrasound).

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Australia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00553657

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.