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

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

DETROL LA (drug)

About this trial

This is an interventional diagnostic trial for Overactive Bladder focused on measuring Experimental Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Full Information

NCT ID

NCT00553657

First Posted

November 2, 2007

Last Updated

October 13, 2010

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00553657

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Experimental Medicine

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

DETROL LA (drug)

Primary Outcome Measure Information:

Title

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

Time Frame

3 consecutive days

Secondary Outcome Measure Information:

Title

Time Frame

3 consecutive days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials, MD

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Randwick, Sydney

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

12. IPD Sharing Statement

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

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