N/A
N=26
Compassionate Use Study of Methylnaltrexone
Opioid-induced Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01368562 ↗Enrolled (actual)
26
Serious AEs
44.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Opioid Induced Side Effects — 3; 1; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methylnaltrexone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Opioid Induced Side Effects |
3; 1; 3; 1; 1; 3 | — |
Summary
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
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.
Data sourced from ClinicalTrials.gov (NCT01368562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.