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 registered on ANZCTR


Registration number
ACTRN12608000160336
Ethics application status
Approved
Date submitted
18/03/2008
Date registered
3/04/2008
Date last updated
14/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study of the impact upon serum electrolyte and magnesium levels of using magnesium sulfate for bowel preparation for colonoscopy.
Scientific title
A prospective study of the impact upon serum electrolyte and magnesium levels of using magnesium sulfate for bowel preparation for colonoscopy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy 2935 0
Condition category
Condition code
Oral and Gastrointestinal 3074 3074 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colocap Balance (TM) 61.75gm magnesium sulfate, encapsulated (65 capsules). Patients will take 65 capsules orally, in batches of 5 with 250ml fluid, every 15 minutes, over a period of approximately 3 hours.
Intervention code [1] 2668 0
Treatment: Drugs
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3958 0
To assess the difference in serum magnesium, urea, creatinine and electrolytes before and after ingesting 61.75gm dried magnesium sulfate.
Timepoint [1] 3958 0
PRE: Up to one week prior to taking bowel preparation, and POST: during colonoscopy procedure.
Secondary outcome [1] 6652 0
To assess the efficacy of the preparation using the colonoscopists evaluation of the quality of the bowel clean.
Timepoint [1] 6652 0
During colonoscopy procedure.
Secondary outcome [2] 6653 0
To assess the acceptability of the bowel preparation to patients using their reports of palatability, ease of use and tolerability.
Timepoint [2] 6653 0
After taking bowel preparation, immediately before procedure.

Eligibility
Key inclusion criteria
Presenting for elective colonoscopy.
Minimum age
18 Years
Maximum age
Not stated
Sex
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
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3186 0
Commercial sector/Industry
Name [1] 3186 0
Colocap Pharmaceuticals
Country [1] 3186 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] 2856 0
None
Name [1] 2856 0
Address [1] 2856 0
Country [1] 2856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5172 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 5172 0
Ethics committee country [1] 5172 0
Australia
Date submitted for ethics approval [1] 5172 0
Approval date [1] 5172 0
Ethics approval number [1] 5172 0
EC00286

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

Contacts
Principal investigator
Name 28444 0
Address 28444 0
Country 28444 0
Phone 28444 0
Fax 28444 0
Email 28444 0
Contact person for public queries
Name 11601 0
Shannon Meyerkort
Address 11601 0
Colocap Pharmaceuticals
Unit 7, 176 Main Street
Osborne Park WA 6017
Country 11601 0
Australia
Phone 11601 0
(08) 9349 2700
Fax 11601 0
Email 11601 0
[email protected]
Contact person for scientific queries
Name 2529 0
Leon Levitt
Address 2529 0
Colocap Pharmaceuticals
Unit 7, 176 Main Street
Osborne Park WA 6017
Country 2529 0
Australia
Phone 2529 0
(08) 9349 2700
Fax 2529 0
Email 2529 0
[email protected]

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.