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Open-Label Treatment Extension of Protocol MNTX 302

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367613
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.

Condition Intervention Phase
Terminal Illness Drug: SC Methylnaltrexone Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Three-Month Open-Label Treatment Extension of Protocol MNTX 302

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 89
Study Start Date: March 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SC Methylnaltrexone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367613


Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367613     History of Changes
Other Study ID Numbers: MNTX 302EXT
First Submitted: May 27, 2011
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Advanced medical illness

Additional relevant MeSH terms:
Methylnaltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents