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N/A N=26 Treatment

Compassionate Use Study of Methylnaltrexone

Opioid-induced Constipation

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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