Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000584639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
4/10/2005
Date last updated
30/10/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy study of HP749, 20mg versus placebo in patients with OAB- UG058-0204
Scientific title
Efficacy study of HP749, 20mg versus placebo in patients with OAB-UG058-0204 (Over active bladders).
Universal Trial Number (UTN)
Trial acronym
UG058-0204
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Over Active Bladders 711 0
Condition category
Condition code
Renal and Urogenital 788 788 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HP749
Intervention code [1] 581 0
Treatment: Drugs
Comparator / control treatment
Placebo 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 1005 0
Improvement of frequency as a change (from baseline to end of the treatment) in mean number of micturitions per 24h.
Timepoint [1] 1005 0
Secondary outcome [1] 1894 0
The proportion of patients cured at week 12 (frequency less than 8 micturitions per day) in the 20mg twice-daily HP749 arm will be compared to the placebo arm.
Timepoint [1] 1894 0
Secondary outcome [2] 1895 0
Evaluation of urodynamic efficacy, in the subpopulation of patients with urodynamic abnormal parameters.
Timepoint [2] 1895 0
At baseline.
Secondary outcome [3] 1896 0
Safety evaluationine.
Timepoint [3] 1896 0

Eligibility
Key inclusion criteria
History of at least 6 months of OAB symptoms, defined as at least 8 micturitions/day, one urgency with or without incontinence episode (at least one/day) and nocturia (to wake at night > 1 time to void). Patients without medication for OAB, or with ineffective and/or unsatisfactory medication for OAB or with a history of ineffective and/or unsatisfactory medication for OAB are included in the trial (wash-out of 2 weeks is mandatory before base-line period and urodynamic examination). Prerequisites for inclusion are no previous bladder training or no current bladder training if started less than one month prior to the trial. Patients with polyuria, urodynamic stress incontinence, renal disease, or bladder outlet obstruction are excluded from the trial, as are patients having any other disease or condition (including neurological disease that could be linked to OAB symptoms) making them unsuitable for participating to the trial.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 873 0
Commercial sector/Industry
Name [1] 873 0
Commercial sponsor
Country [1] 873 0
Primary sponsor type
Commercial sector/Industry
Name
UroGene SA
Address
Country
France
Secondary sponsor category [1] 739 0
Commercial sector/Industry
Name [1] 739 0
ORION Clinical Services (Aust) Pty Ltd
Address [1] 739 0
Country [1] 739 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2153 0
Prince of Wales Hospital
Ethics committee address [1] 2153 0
Ethics committee country [1] 2153 0
Australia
Date submitted for ethics approval [1] 2153 0
Approval date [1] 2153 0
Ethics approval number [1] 2153 0
Ethics committee name [2] 2154 0
Royal Melbourne Hospital
Ethics committee address [2] 2154 0
Ethics committee country [2] 2154 0
Australia
Date submitted for ethics approval [2] 2154 0
Approval date [2] 2154 0
Ethics approval number [2] 2154 0
Ethics committee name [3] 2155 0
Royal Brisbane & Women's Hospital
Ethics committee address [3] 2155 0
Ethics committee country [3] 2155 0
Australia
Date submitted for ethics approval [3] 2155 0
Approval date [3] 2155 0
Ethics approval number [3] 2155 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35807 0
Address 35807 0
Country 35807 0
Phone 35807 0
Fax 35807 0
Email 35807 0
Contact person for public queries
Name 9770 0
Yvonne Egan Davidson
Address 9770 0
ORION Clinical Services Australia Pty Ltd
Level 1
141 Osborne Street
South Yarra VIC 3141
Country 9770 0
Australia
Phone 9770 0
+61 3 98671064
Fax 9770 0
+61 3 98671086
Email 9770 0
yvonne.egandavidson@orioncro.com
Contact person for scientific queries
Name 698 0
Yvonne Egan Davidson
Address 698 0
ORION Clinical Services Australia Pty Ltd
Level 1
141 Osborne Street
South Yarra VIC 3141
Country 698 0
Australia
Phone 698 0
+61 3 98671064
Fax 698 0
+61 3 98671086
Email 698 0
yvonne.egandavidson@orioncro.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.