Compassionate Use Study of Methylnaltrexone

NCT ID: NCT01368562

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-24
• Study Completion Date: 2008-06-02

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.

Conditions

Opioid-induced Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylnaltrexone

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.

Group Type: EXPERIMENTAL

Methylnaltrexone

Intervention Type: DRUG

Methylnaltrexone will be administered as per the dose and schedule specified in the arm.

Interventions

Methylnaltrexone

Methylnaltrexone will be administered as per the dose and schedule specified in the arm.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsey Mathew

Role: STUDY_DIRECTOR

Bausch Health Companies

Locations

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Countries

United States

Other Identifiers

MNTX 901

Identifier Type: -

Identifier Source: org_study_id