Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

Bausch Health Americas, Inc.

Overview

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Opioid-Induced Constipation

Interventions

methylnaltrexoneDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is a man or woman aged 18 years or older. * Has a body weight \>= 38 kg. * Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). * Has a life expectancy of \>= 6 months. * Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale. * Is taking opioids for cancer-related pain, and not just as-needed doses. * Has a diagnosis of OIC as determined by the investigator. * Is willing to follow the protocol instructions on laxative use during the study. Exclusion Criteria: * Has a history of chronic constipation before starting opioids. * Has renal disease receiving dialysis. * Has an ostomy for stools. * Is a pregnant or breastfeeding woman.

Locations (8)

Pfizer Investigational Site

Laguna Hills, California, United States

Pfizer Investigational Site

Lancaster, California, United States

Pfizer Investigational Site

Flat Rock, North Carolina, United States

Pfizer Investigational Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.

Time frame: 1 Day

Secondary Outcomes

1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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