Open-Label Treatment Extension of Protocol MNTX 302

This study has been completed.
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01367613
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: May 27, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 21, 2016