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This is an open label compassionate use study of subcutaneously administered MNTX in subjects with advance medical illness and opioid-induced constipation. Eligible subjects were to initially receive a single dose of MNTX delivered SC. Subsequent dosing could have been adjusted upward to achieve a desired clinical response or lowered to alleviate drug related adverse events (AEs).
Condition or disease
Valeant Pharmaceuticals International, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Advanced medical illness (i.e. terminal illness, such as incurable cancer or end stage 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
On a laxative regimen (e.g. stool softener and SENNA or equivalent) for at least 3 days prior to treatment.
Patients with known hypersensitivity to methylnaltrexone, naltrexone or naloxone
Patients 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
Patients who are constipated and have active, clinically significant diverticulitis
Patients being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure