Open-Label Treatment Extension of Protocol MNTX 302

Phase 3

Completed

• Conditions: Terminal Illness
• Interventions: Drug: SC Methylnaltrexone

• Registration Number: NCT01367613
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2006-01
• Study Completion: 2006-01
• 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: 89

Inclusion Criteria

1. Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
2. Negative pregnancy test
3. Stable vital signs

Exclusion Criteria

1. Women who are pregnant and/or nursing
2. Received any investigational product, other than MNTX, in the past 30 days
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	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	3 months	To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302

Trial Locations

Locations (1)

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