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Trial registered on ANZCTR
Registration number
ACTRN12611000717954
Ethics application status
Approved
Date submitted
8/07/2011
Date registered
11/07/2011
Date last updated
16/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy of clorpactin('registered trademark (R)) in bladder pain syndrome/interstitial cystitis: a randomised placebo-controlled trial
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Scientific title
Efficacy of clorpactin(R) in bladder pain syndrome/interstitial cystitis: a randomised placebo-controlled trial
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Secondary ID [1]
262597
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bladder pain syndrome/interstitial cystitis
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Condition category
Condition code
Renal and Urogenital
268418
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Clorpactin (sodium oxychlorosene) 0.4% solution (2gm in 500ml sterile water) given as a single intravesical instillation under general anaesthetic
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Intervention code [1]
266935
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Treatment: Drugs
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Comparator / control treatment
Placebo (cystodistension) - distension for 4 minutes having been filled to capacity under 80 cm of water pressure
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Subject improvement as reflected in the Global response assessment
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Assessment method [1]
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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NIl
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Eligibility
Key inclusion criteria
Females 18-70 years old
Diagnosed with bladder pain syndrome/interstitial cystitis
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Allergy to clorpactin(R) or it’s constituent parts
History of renal impairment or vesico-ureteric reflux
Contraindication to general anaesthetic
Unable to sign consent
Unable to attend followup or complete questionnaires
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2012
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Actual
1/03/2012
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Date of last participant enrolment
Anticipated
31/12/2015
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Actual
31/12/2016
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Date of last data collection
Anticipated
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Actual
31/12/2017
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Sample size
Target
54
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
267408
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Mercy Hospital for Women
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Address
163 Studley Rd
Heidelberg
Vic 3084
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Monash Medical Centre
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Address [1]
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246 Clayton Road
Clayton
VIC 3168
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Country [1]
266464
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Mercy Public Health Inc
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Ethics committee address [1]
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163 Studley Rd, Heidelberg VIC 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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11/07/2011
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Approval date [1]
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02/02/2012
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Ethics approval number [1]
269375
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R11/63
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Summary
Brief summary
A randomised trial assessing the efficacy of Clorpactin instillation in women with Bladder pain syndrome/Interstitial cystitis
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kristina Cvach
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Address
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Mercy Hospital for Women
163 Studley Rd Heidelberg VIC 3084
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Country
32855
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Australia
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Phone
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+61 3 8458 4862
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr. Kristina Cvach
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Address
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Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
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Country
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Australia
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Phone
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+61 3 8458 4862
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr. Kristina Cvach
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Address
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Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
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Country
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Australia
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Phone
7030
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+61 3 8458 4862
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Fax
7030
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Email
7030
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Review of intravesical therapies for bladder pain syndrome/interstitial cystitis.
2015
https://dx.doi.org/10.3978/j.issn.2223-4683.2015.10.07
Embase
Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.
2020
https://dx.doi.org/10.1002/14651858.CD013325.pub2
Embase
Efficacy of Clorpactin in refractory bladder pain syndrome/interstitial cystitis: a randomized controlled trial.
2021
https://dx.doi.org/10.1007/s00192-020-04652-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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