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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00553657
First received: November 2, 2007
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

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)
Intervention Details:
    Drug: DETROL LA (drug)
    Other Name: DETROL LA (drug)
  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: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00553657     History of Changes
Other Study ID Numbers: BKB105190
Study First Received: November 2, 2007
Last Updated: October 13, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Experimental Medicine

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013