Methylnaltrexone for Opioid-induced Constipation in Cancer Patients

Completed · Phase 2

Conditions studied: Neoplasms, Constipation, Opioid-Related Disorders

In brief

The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.

Key facts

Study ID

NCT01004393

Run by

University of Vermont

People needed

12

Starts

2009-10-01

Expected to finish

2013-12-01

Last updated by the study team

2016-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed neoplasm
• 18 years of age or older
• Have received opioids for analgesia for at least 2 weeks and been on a stable regimen of opioids and laxatives for 3 or more days before study entry
• Fewer than three laxation during the preceding week and no laxation within 24 hours before study entry, or no laxation within 48 hours before study entry
• Life expectancy of at least 6 months
• World Health Organization Performance Status 0-3
• Women of childbearing potential must have a negative pregnancy test
• Breastfeeding should be discontinued prior to study entry
• Ability to understand and the willingness to sign a written informed consent document.
• Laboratory values within a week of study entry:
• Absolute neutrophil count > 1,500/microliter Hemoglobin > 7 g/dL Platelet count > 100,000/microliter Calculated calcium < 10.5 mg/dL Calculated creatinine clearance > 30 mg.min Alanine aminotransferase < 3 x upper limit of normal (ULN) Aspartate aminotransferase < 3 x ULN Alkaline phosphatase < 2.5 x ULN Bilirubin < 1.5 x ULN

You may not qualify if…

• Constipation not primarily caused by opioids, such as mechanical gastrointestinal obstruction or ongoing vinca alkaloid administration
• Indwelling peritoneal catheter
• Clinically active diverticular disease
• Fecal impaction
• Acute surgical abdomen
• Fecal ostomy
• Peritoneal carcinomatosis
• Known hypersensitivity to methylnaltrexone, naltrexone, or naloxone
• Administration of any investigational drug or experimental product within the previous 30 days
• Initiation of a new bowel regimen or prokinetic agents within a week of study entry

Where it is running

• Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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