Compassionate Use Study of Methylnaltrexone

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

Official Title
-----------------
A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects

Conditions
-----------------
Opioid-induced Constipation

Intervention / Treatment
-----------------
* Drug: Methylnaltrexone


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylnaltrexone<br>Participants will receive single dose of MNTX 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC). Subsequent dosing could be adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. | Drug: Methylnaltrexone<br>* Methylnaltrexone will be administered as per the dose and schedule specified in the arm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Opioid Induced Side Effects | Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | From start of treatment until end of study (up to maximum 3.4 years) |