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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000081213

Acronym

EFDSCN308

Enrollment

100

Registered

2009-02-04

Start date

2008-09-06

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Healthy volunteers

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.

Exclusion criteria

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

Outcome results