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Trial registered on ANZCTR


Registration number
ACTRN12609000081213
Ethics application status
Approved
Date submitted
6/01/2009
Date registered
4/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A 12 week prospective study of efficacy and acceptability of magnesium sulfate once weekly in adults as a management regime for constipation.
Scientific title
A 12 week prospective study of efficacy and acceptability of magnesium sulfate once weekly in adults as a management regime for constipation.
Universal Trial Number (UTN)
Trial acronym
EFDSCN308
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 3628 0
Condition category
Condition code
Oral and Gastrointestinal 3791 3791 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Encapsulated magnesium sulfate. Capsules containing dried magnesium sulfate, an osmotic laxative which draws water into the bowel making it easy to pass stool. Individual dosage will vary according to need, but will range between 5-45 capsules, and average between 10-20 capsules. Each capsule contains 950mg of magnesium sulfate. The dosage will be taken orally, once weekly for 12 weeks.
Intervention code [1] 3339 0
Treatment: Drugs
Comparator / control treatment
Participants will be their own comparator group, comparing constipation symptoms and laxative use prior to enrolling on the study, with their symptoms and laxative use (other than Investigational Product) while on the study.
Control group
Historical

Outcomes
Primary outcome [1] 4687 0
To assess the efficacy of magnesium sulfate at variable dosages (up to 65 capsules, 61.75mg) as an ongoing weekly treatment for chronic constipation, measured by an improvement in constipation symptoms. Constipation symptoms will include frequency of opening bowels, time spent on toilet, degree of straining, unsuccessful trips to the toilet, incomplete evacuation, the urge to open the bowels, use of aperients and a range of quality of life questions. All symptoms will be assessed using a patient-completed questionnaires, provided at the initial visit, then repeated at 6 and 12 weeks.
Timepoint [1] 4687 0
6 weeks and 12 weeks
Primary outcome [2] 4688 0
To assess the acceptability of magnesium sulfate to patients as an ongoing weekly treatment for constipation (palatability, tolerability, compliance, ease of use). Palatability and ease of use will be measured using patient completed questionnaires, with 5-point scales. Compliance is assessed by the trial staff checking the remaining capsules in the bottles, and tolerability will be assessed by measuring the frequency and severity of side effects, which may include headache, bloating, soreness of back passage, and nausea.
Timepoint [2] 4688 0
6 weeks and 12 weeks
Secondary outcome [1] 7903 0
To assess patient satisfaction with their bowel habits during the trial period compared to their previous habits. Satisfaction will be a composite measure based on change over time for a number of measures including constipation symptoms and quality of life; also a reduction in anxiety and physical discomfort levels; and the reoccurance of spontaneous bowel actions.
Timepoint [1] 7903 0
6 weeks and 12 weeks

Eligibility
Key inclusion criteria
Diagnosis of constipation (defined as difficulty with rectal evacuation requiring oral or topical laxatives at least once weekly) for at least 6 months.
Minimum age
18 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known adverse reaction to magnesium sulfate.
Known renal failure.
Pregnancy or breastfeeding.

Study design
Purpose of the study
Treatment
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
Participants will be their own comparator group, comparing constipation symptoms and laxative use prior to enrolling on the study, with their symptoms and laxative use (other than Investigational Product) while on the study.
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] 3807 0
Commercial sector/Industry
Name [1] 3807 0
Colocap Pharmaceuticals Pty Ltd
Address [1] 3807 0
U7, 176 Main Street
Osborne Park WA 6017
Country [1] 3807 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Colocap Pharmaceuticals Pty Ltd
Address
U7, 176 Main Street
Osborne Park WA 6017
Country
Australia
Secondary sponsor category [1] 3416 0
None
Name [1] 3416 0
Address [1] 3416 0
Country [1] 3416 0
Other collaborator category [1] 391 0
Hospital
Name [1] 391 0
Fremantle Hospital
Address [1] 391 0
Alma Road, Fremantle WA 6160
Country [1] 391 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5862 0
South Metropolitan Area Human Research Ethics Committee
Ethics committee address [1] 5862 0
PO Box 480
Fremantle WA 6160
Ethics committee country [1] 5862 0
Australia
Date submitted for ethics approval [1] 5862 0
20/05/2008
Approval date [1] 5862 0
23/07/2008
Ethics approval number [1] 5862 0
EC00265

Summary
Brief summary
The aim of the study is to determine how well a once-weekly dose of Colocap Balance (magnesium sulfate) works in the treatment of chronic constipation. The study hypothesis is that a single, weekly dose of capsules, sufficient to create a strong urge to open the bowel and empty the bowel, will lead to an improvement in constipation symptoms, allow for a reduction in laxative use, and encourage the bowel to start working spontaneously between doses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28889 0
Address 28889 0
Country 28889 0
Phone 28889 0
Fax 28889 0
Email 28889 0
Contact person for public queries
Name 12046 0
Shannon Meyerkort
Address 12046 0
Colocap Pharmaceuticals
U7, 176 Main Street
Osborne Park WA 6017
Country 12046 0
Australia
Phone 12046 0
+61 8 9349 2700
Fax 12046 0
+61 8 9349 2711
Email 12046 0
shannon@colocap.com.au
Contact person for scientific queries
Name 2974 0
Dr Leon Levitt
Address 2974 0
Colocap Pharmaceuticals
U7, 176 Main Street
Osborne Park WA 6017
Country 2974 0
Australia
Phone 2974 0
+61 8 9349 2700
Fax 2974 0
+61 8 9349 2711
Email 2974 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