Trial Review

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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
Scientific title
Efficacy of clorpactin(R) in bladder pain syndrome/interstitial cystitis: a randomised placebo-controlled trial
Secondary ID [1] 262597 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder pain syndrome/interstitial cystitis 268284 0
Condition category
Condition code
Renal and Urogenital 268418 268418 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 266935 0
Treatment: Drugs
Comparator / control treatment
Placebo (cystodistension) - distension for 4 minutes having been filled to capacity under 80 cm of water pressure
Control group
Placebo

Outcomes
Primary outcome [1] 269172 0
Subject improvement as reflected in the Global response assessment
Timepoint [1] 269172 0
3 months
Secondary outcome [1] 279063 0
Nil
Timepoint [1] 279063 0
NIl

Eligibility
Key inclusion criteria
Females 18-70 years old
Diagnosed with bladder pain syndrome/interstitial cystitis
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
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

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)
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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
1/03/2012
Date of last participant enrolment
Anticipated
31/12/2015
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
54
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267408 0
Self funded/Unfunded
Name [1] 267408 0
Country [1] 267408 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Rd
Heidelberg
Vic 3084
Country
Australia
Secondary sponsor category [1] 266464 0
Hospital
Name [1] 266464 0
Monash Medical Centre
Address [1] 266464 0
246 Clayton Road
Clayton
VIC 3168
Country [1] 266464 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269375 0
Mercy Public Health Inc
Ethics committee address [1] 269375 0
Ethics committee country [1] 269375 0
Australia
Date submitted for ethics approval [1] 269375 0
11/07/2011
Approval date [1] 269375 0
02/02/2012
Ethics approval number [1] 269375 0
R11/63

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

Contacts
Principal investigator
Name 32855 0
Dr Kristina Cvach
Address 32855 0
Mercy Hospital for Women
163 Studley Rd Heidelberg VIC 3084
Country 32855 0
Australia
Phone 32855 0
+61 3 8458 4862
Fax 32855 0
Email 32855 0
kcvach@mercy.com.au
Contact person for public queries
Name 16102 0
Dr. Kristina Cvach
Address 16102 0
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
Country 16102 0
Australia
Phone 16102 0
+61 3 8458 4862
Fax 16102 0
Email 16102 0
kcvach@mercy.com.au
Contact person for scientific queries
Name 7030 0
Dr. Kristina Cvach
Address 7030 0
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
Country 7030 0
Australia
Phone 7030 0
+61 3 8458 4862
Fax 7030 0
Email 7030 0
kcvach@mercy.com.au

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
SourceTitleYear of PublicationDOI
EmbaseReview of intravesical therapies for bladder pain syndrome/interstitial cystitis.2015https://dx.doi.org/10.3978/j.issn.2223-4683.2015.10.07
EmbaseInterventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.2020https://dx.doi.org/10.1002/14651858.CD013325.pub2
EmbaseEfficacy of Clorpactin in refractory bladder pain syndrome/interstitial cystitis: a randomized controlled trial.2021https://dx.doi.org/10.1007/s00192-020-04652-3
N.B. These documents automatically identified may not have been verified by the study sponsor.