Compassionate Use Study of Methylnaltrexone

• Status: Completed
• Trial end date: 2008-06-02
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

• Advanced medical illness (that is; terminal illness, such as incurable cancer or end stage aqcuired immunodeficiency syndrome [AIDS]) with a life expectancy of one to six months.

• On an opioid regimen for the control of pain/discomfort for at least seven days.

• Has opioid-induced constipation.

• Stable vital signs and systolic blood pressure greater than or equal to (>=) 85 millimeters of mercury (mmHg), and diastolic blood pressure >=45 mmHg (Supine or sitting).

• Females of childbearing potential must have a negative pregnancy test (serum or urine).

• On a laxative regimen (for example, stool softener and SENNA or equivalent) for at least 3 days prior to treatment. Participants who have discontinued laxatives due to intolerability or lack of efficacy are also eligible.

Exclusion Criteria:

• Participants with known hypersensitivity to methylnaltrexone, naltrexone or naloxone.

• Participants who received any investigational new drug (experimental) except for methylnaltrexone in the previous 30 days.

• Participants who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction.

• Participants who are constipated and have active, clinically significant diverticulitis.

• Participants with a surgically acute abdomen.

• Participants being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure.

• Individuals with a known drug addiction.

• Females who are pregnant or nursing.