A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of Oral Naloxone for the Treatment of Opioid-Induced Constipation in Patients With Chronic, Non-Malignant Pain or Malignant Pain
OBJECTIVES: I. Assess the long-term safety and efficacy of oral naloxone in treating
opioid-induced constipation in patients with chronic malignant or non-malignant pain.
OUTLINE: This is a multicenter study. Patients receive oral naloxone twice daily. Each
patient receives an escalating dose until the minimum effective dose or the maximum dose
allowed is reached. The minimum effective dose is defined as the dose at which a patient has
at least 4 bowel movements within 7 days. Patients receive the minimum effective dose for 7
days and then continue long-term treatment for a maximum of 72 weeks. Patients receiving the
maximum dose allowed with fewer than 4 bowel movements per week will discontinue study
PROJECTED ACCRUAL: Approximately 600 patients will be accrued for this study.
Primary Purpose: Supportive Care
Nathaniel Katz, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Brigham and Women's Hospital||Boston, Massachusetts 02115|