Compassionate Use Study of Methylnaltrexone

Opioid-induced Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368562
• Other study ID #: MNTX 901
• Status: Completed
• Phase: N/A
• Start date: January 24, 2003
• Est. completion date: June 2, 2008

Study information

• Verified date: August 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2, 2008
• Est. primary completion date: June 2, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

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

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)