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NCT00672477 Clinical Trial

Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

Opioid-Induced Constipation Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00672477
Other study ID # 3200K1-4000
Secondary ID B2541005
Status Completed
Phase Phase 4
First received May 2, 2008
Last updated February 7, 2018
Start date June 2008
Est. completion date February 2013

Study information
Verified date February 2018
Source Valeant Pharmaceuticals International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methylnaltrexone

• Placebo

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Sponsors (2)
Lead Sponsor Collaborator
Valeant Pharmaceuticals International, Inc. Progenics Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation. 7 days
Secondary Time to First Rescue-free Laxation (Following the First Dose of Study Drug). This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation. 14 days
See also
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Completed NCT01186770 - A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain Phase 3
Completed NCT02270983 - Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain Phase 2
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Recruiting NCT03687268 - Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation Phase 3
Completed NCT00672139 - Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness Phase 4
Terminated NCT01901341 - The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation Phase 3
Recruiting NCT03720613 - Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain
Completed NCT01368562 - Compassionate Use Study of Methylnaltrexone N/A
Completed NCT01040637 - A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation Phase 1/Phase 2
Recruiting NCT05133076 - Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications Phase 2