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Open-Label Treatment Extension of Protocol MNTX 302

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ClinicalTrials.gov Identifier: NCT01367613
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

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

Condition or disease Intervention/treatment Phase
Terminal Illness Drug: SC Methylnaltrexone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: SC Methylnaltrexone



Primary Outcome Measures :
  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



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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

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.

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367613     History of Changes
Other Study ID Numbers: MNTX 302EXT
First Posted: June 7, 2011    Key Record Dates
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