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OpenTrials
Completed

NCT Number: NCT01367600

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.

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Key information

Conditions

Terminal Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Progenics Pharmaceuticals

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women who are pregnant and/or nursing
  • Any concurrent experimental drug therapy
  • Evidence of fecal impaction
  • Clinically significant active diverticular disease

Treatment and study plan

SC Methylnaltrexone (MNTX)

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jun 7, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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