Trial | NCT01367574  Report issue

Title

Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    39
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.
Study Started
Apr 30
2002
Primary Completion
May 31
2003
Study Completion
May 31
2003
Last Update
Nov 27
2019

Drug SC MNTX

Dose 1

Drug SC MNTX

Dose 2

Drug SC MNTX

Dose 3

Arm 1 Experimental

Arm 2 Experimental

Arm 3 Experimental

Criteria 

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
No Results Posted