Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00553657




Registration number
NCT00553657
Ethics application status
Date submitted
2/11/2007
Date registered
4/11/2007
Date last updated
26/10/2010

Titles & IDs
Public title
The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive Bladder
Scientific 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
Secondary ID [1] 0 0
BKB105190
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DETROL LA (drug)

Treatment: Drugs: DETROL LA (drug)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Variability of change from baseline in mean volume per void measured on 3 consecutive days.
Timepoint [1] 0 0
3 consecutive days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 consecutive days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 ß-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).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00553657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00553657