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OpenTrials
Completed

NCT Number: NCT01367613

Open-Label Treatment Extension of Protocol MNTX 302

This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 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, Inc.

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

  • 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.
  • Negative pregnancy test
  • Stable vital signs

Exclusion criteria

  • Women who are pregnant and/or nursing
  • Received any investigational product, other than MNTX, in the past 30 days
  • Evidence of fecal impaction
  • Clinically significant active diverticular disease

Treatment and study plan

SC Methylnaltrexone

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 3 months

    To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302

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 302

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
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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