Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000337471
Ethics application status
Approved
Date submitted
20/06/2007
Date registered
25/06/2007
Date last updated
25/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing Phospo-Soda Buffered Saline (Fleet ®) with Sodium Picosulphate/Magnesium Citrate (Picoprep ®) in the preparation of patients for colonoscopy".
Scientific title
A Randomised Controlled Trial (RCT) comparing the efficacy and acceptability of Phospo-Soda Buffered Saline (Fleet ®) with Sodium Picosulphate/Magnesium Citrate (Picoprep ®) in the preparation of patients for colonoscopy.
Universal Trial Number (UTN)
Trial acronym
Fleet V Picoprep
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel prepartion for colonoscopy 1888 0
Condition category
Condition code
Oral and Gastrointestinal 1983 1983 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised prospective trial designed to compare the efficacy and acceptability of phospo-soda buffered saline (Fleet ®)(control) with sodium picosulphate/ magnesium citrate (Picoprep ®) (intervention) in patients undergoing colonoscopy.The prepartion All patients also received 3 Bisacodyl tablets (Dulcolax, Boehringer Ingelheim, Germany) 2 days before the procedure (one day before phospo-soda buffered saline (Fleet) or sodium picosulphate/ magnesium citrate (picoprep)). Patients were encouraged to drink freely of clear fluids while taking the preparation in line with the manufacturer’s instructions, while obstaining from solid food for 24 hours prior to colonoscopy
Intervention code [1] 1844 0
Other interventions
Comparator / control treatment
Saline (Fleet ®)(control)
Control group
Active

Outcomes
Primary outcome [1] 2804 0
The efficacy and acceptability of each preparation at time of colonoscopy as the primary end point relates to the ablity to do the colonoscopy.
Timepoint [1] 2804 0
At time of colonoscopy
Secondary outcome [1] 4729 0
Complications associated with bowel preparation before colonoscopy.
Timepoint [1] 4729 0
Assessed immediately before colonoscopy (within 5 minutes of the colonoscopy being done).

Eligibility
Key inclusion criteria
All patients (male and female, over 16 years , no maximum age limit) coming forward for colonoscopy who were fit for procedure.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, suspected or known obstructing lesion.

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)
Closed envelopes with randomisation enclosed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Flip of coin
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
73
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2123 0
Self funded/Unfunded
Name [1] 2123 0
Frank Frizelle
Country [1] 2123 0
Primary sponsor type
Individual
Name
Frank Frizelle
Address
Country
Secondary sponsor category [1] 1930 0
None
Name [1] 1930 0
None
Address [1] 1930 0
Country [1] 1930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3916 0
Oxford Clinic Ethics Committee
Ethics committee address [1] 3916 0
Ethics committee country [1] 3916 0
Australia
Date submitted for ethics approval [1] 3916 0
Approval date [1] 3916 0
17/11/2003
Ethics approval number [1] 3916 0

Summary
Brief summary
The adequacy and efficacy of various small-volume bowel preparations for colonoscopy has become increasingly popular due to improved tolerance by patients and equivalent efficacy compared with the larger volume preparations. Comparative studies however between small volume preparations are lacking. This randomised controlled trial aims to compare the efficacy and acceptability of phospo-soda buffered saline (Fleet ®) with sodium picosulphate/ magnesium citrate (Picoprep ®) in the preparation of patients for colonoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27658 0
Address 27658 0
Country 27658 0
Phone 27658 0
Fax 27658 0
Email 27658 0
Contact person for public queries
Name 11033 0
Professor Frank Frizelle
Address 11033 0
Colorectal Unit
Christchurch Hospital
Riccarton Ave
Chrstchurch
Country 11033 0
New Zealand
Phone 11033 0
+64 3 3640640
Fax 11033 0
+64 3 3640352
Email 11033 0
[email protected]
Contact person for scientific queries
Name 1961 0
Professor Frank Frizelle
Address 1961 0
Colorectal Unit
Christchurch Hospital
Riccarton Ave
Chrstchurch
Country 1961 0
New Zealand
Phone 1961 0
+64 3 3640640
Fax 1961 0
+64 3 3640352
Email 1961 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.