A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

Phase 3

Completed

• Conditions: Advanced Illness Patients With Opioid Induced Constipation
• Interventions: Drug: SC Methylnaltrexone; Drug: SC Placebo

• Registration Number: NCT00401362
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

To test the effectiveness of MNTX in advanced illness subjects.

Detailed Description

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Advanced medical illness with a life expectancy of 1 to 6 months
2. No clinically significant laxation within 48 hours prior to the first dose of study drug
3. On stable opioid and laxative regimen for a least 3 days prior to treatment
4. Age greater than 18years
5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria

1. Females who are pregnant or nursing.
2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
3. Any disease process suggestive of gastrointestinal obstruction
4. Fecal ostomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	SC Methylnaltrexone	-
Arm 3	SC Placebo	-
Arm 2	SC Methylnaltrexone	-

Primary Outcome Measures

Name	Time	Method
Efficacy of SC MNTX compared with placebo in inducing laxation	29 days	The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States