Open-Label Treatment Extension of Protocol MNTX 301

Phase 3

Completed

• Conditions: Terminal Illness
• Interventions: Drug: SC Methylnaltrexone (MNTX)

• Registration Number: NCT01367600
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment
2. Negative pregnancy test

Exclusion Criteria

1. Women who are pregnant and/or nursing
2. Any concurrent experimental drug therapy
3. Evidence of fecal impaction
4. Clinically significant active diverticular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	SC Methylnaltrexone (MNTX)	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	3 months	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pain scores	3 months	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.
Number of patients with opioid withdrawal symptoms	3 months	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Trial Locations

Locations (1)

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