The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive Bladder
This study has been completed.
Information provided by:
First received: November 2, 2007
Last updated: October 13, 2010
Last verified: October 2010
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.
Drug: DETROL LA (drug)
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553657
|GSK Investigational Site
|Randwick, Sydney, New South Wales, Australia, 2031 |
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 2007
||October 13, 2010
||Australia: Department of Health and Ageing Therapeutic Goods Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Urinary Bladder, Overactive
Urinary Bladder Diseases
Lower Urinary Tract Symptoms
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs