Compassionate Use Study of Methylnaltrexone

NCT01368562 | Completed Results

• 1 other identifier: MNTX 901
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Methylnaltrexone

EXPERIMENTAL

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

Interventions

Methylnaltrexone DRUG

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

Methylnaltrexone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Companies

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Companies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 8, 2011
• Study Start: January 24, 2003
• Primary Completion: June 2, 2008
• Study Completion: June 2, 2008
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Locations

US (1)