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Trial registered on ANZCTR


Registration number
ACTRN12608000269336
Ethics application status
Approved
Date submitted
20/05/2008
Date registered
28/05/2008
Date last updated
27/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A single blinded, randomised study to compare efficacy and acceptability of magnesium sulfate capsules (Colocap: Balance) with sodium picosulfate (Pharmatel Fresenius Kabi: Picoprep) for bowel cleansing prior to colonoscopy.
Scientific title
A single blinded, randomised study to compare efficacy and acceptability of magnesium sulfate capsules (Colocap: Balance) with sodium picosulfate (Pharmatel Fresenius Kabi: Picoprep) for bowel cleansing prior to colonoscopy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy 3171 0
Condition category
Condition code
Oral and Gastrointestinal 3330 3330 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnesium sulfate, encapsulated (65 capsules), total 61.75g (Colocap Balance), single administration before the procedure
Intervention code [1] 2903 0
Treatment: Drugs
Comparator / control treatment
Sodium picosulfate, powder, 3 sachets (Picoprep), single administration before the procedure
Control group
Active

Outcomes
Primary outcome [1] 4217 0
To evaluate the efficacy of 65 capsules of magnesium sulfate compared with 3 sachets of sodium picosulfate using the clinician's blinded evaluation of the quality of the bowel clean using the validated Ottawa Bowel Preparation Score
Timepoint [1] 4217 0
During the colonoscopy procedure
Secondary outcome [1] 7134 0
To evaluate patients' assessment of overall acceptability of magnesium sulfate compared with sodium picosulfate using their reports of palatability, ease of use (compliance) and tolerability (side effects) using a patient-completed assessment form.
Timepoint [1] 7134 0
After taking the bowel preparation, before the colonoscopy procedure

Eligibility
Key inclusion criteria
Presenting for elective colonoscopy
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal insufficiency, current chronic inflammatory bowel disease

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)
Each Investigator will be assigned a group of numbered patient kits, each pre-packed according to the randomisation schedule with either instructions on how to take sodium picosulfate or magnesium sulfate. Each new enrolling patient will be allocated the next sequential patient pack. A third person (practice manager, nurse etc) will check the contents of the pack to see which treatment/medication should be provided to the patient. Patients and practice managers will be told not to discuss treatment with their doctors at any stage. Doctors will explain both treatments in detail during the consenting process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomised numbers
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3404 0
Commercial sector/Industry
Name [1] 3404 0
Colocap Pharmaceuticals
Address [1] 3404 0
Unit 7, 176 Main Street
Osborne Park WA 6017
Country [1] 3404 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Colocap Pharmaceuticals
Address
Unit 7, 176 Main Street
Osborne Park WA 6017
Country
Australia
Secondary sponsor category [1] 3048 0
None
Name [1] 3048 0
Address [1] 3048 0
Country [1] 3048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5433 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 5433 0
Level 3, St John of God House
177-179 Cambridge St
Subiaco WA 6008
Ethics committee country [1] 5433 0
Australia
Date submitted for ethics approval [1] 5433 0
Approval date [1] 5433 0
04/04/2008
Ethics approval number [1] 5433 0
EC00286

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

Contacts
Principal investigator
Name 28602 0
Address 28602 0
Country 28602 0
Phone 28602 0
Fax 28602 0
Email 28602 0
Contact person for public queries
Name 11759 0
Shannon Meyerkort
Address 11759 0
Colocap Pharmaceuticals
Unit 7, 176 Main Street
Osborne Park WA 6017
Country 11759 0
Australia
Phone 11759 0
(08) 9349 2700
Fax 11759 0
(08) 9349 2711
Email 11759 0
shannon@colocap.com.au
Contact person for scientific queries
Name 2687 0
Dr Leon Levitt
Address 2687 0
Colocap Pharmaceuticals
Unit 7, 176 Main Street
Osborne Park WA 6017
Country 2687 0
Australia
Phone 2687 0
(08) 9349 2700
Fax 2687 0
(08) 9349 2711
Email 2687 0
leon@colocap.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary