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

Opioid-Induced Constipation Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00858754
• Other study ID #: 3200K1-4006
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2009
• Est. completion date: August 2009

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• methylnaltrexone

• placebo

Locations

Country	Name	City	State
	Pfizer Investigational Site
Canada	Pfizer Investigational Site	Edmonton	Alberta
France	Pfizer Investigational Site	Villejuif Cedex
Spain	Pfizer Investigational Site	El Palmar	Murcia/Spain
United States	Pfizer Investigational Site	Flat Rock	North Carolina
United States	Pfizer Investigational Site	Laguna Hills	California
United States	Pfizer Investigational Site	Lancaster	California
United States	Pfizer Investigational Site	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Progenics Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.		1 Day
Secondary	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.		2 weeks

External Links

•   To obtain contact information for a study center near you, click here.