CompletedPhase 2

Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

United States39 participantsStarted 2002-04

Plain-language summary

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
✓. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
✓. Must have constipation
✓. Must be 18 yrs or older

Exclusion criteria

✕. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
✕. Patients who received any experimental drug in the last 30 days
✕. Patients with active peritoneal cancer (ovarian, etc.)
✕. Patients with active diverticulitis or diverticulosis

What they're measuring

Number of subjects who have a bowel movement within four hours of dosing

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT01367574

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-05

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