ActivePhase 3ACTRN12609000081213

A 12 week prospective study of efficacy and acceptability of magnesium sulfate once weekly in adults as a management regime for constipation.

Sponsor

Colocap Pharmaceuticals Pty Ltd

Enrollment

100 participants

Start Date

Sep 6, 2008

Study Type

Interventional

Conditions

Constipation

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 79 Yearss

Inclusion Criteria1

Diagnosis of constipation (defined as difficulty with rectal evacuation requiring oral or topical laxatives at least once weekly) for at least 6 months.

Exclusion Criteria3

Known adverse reaction to magnesium sulfate.
Known renal failure.
Pregnancy or breastfeeding.

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Interventions

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 v

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.