Open-Label Treatment Extension of Protocol MNTX 301

November 26, 2019 updated by: Bausch Health Americas, Inc.

A Three-Month Open-Label Treatment Extension of Protocol MNTX 301

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Tarrytown, New York, United States, 10591
        • Progenics Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: SC Methylnaltrexone (MNTX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: 3 months
To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNTX 301EXT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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