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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00553657

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: DETROL LA (drug)	Phase I

MedlinePlus related topics: Urine and Urination

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

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 ]

Enrollment:	55
Study Start Date:	August 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553657

Locations

Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	BKB105190
Study First Received:	November 2, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00553657 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

Experimental Medicine

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele

Cholinergic Antagonists
Urologic Diseases
Urinary Bladder Diseases
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Tolterodine

ClinicalTrials.gov processed this record on May 06, 2009