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Open-Label Treatment Extension of Protocol MNTX 301

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367600
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.


Condition Intervention Phase
Terminal Illness
 Drug: SC Methylnaltrexone (MNTX)
 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 301

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.


Secondary Outcome Measures:
  • Change from baseline in pain scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

  • Number of patients with opioid withdrawal symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.


Enrollment: 27
Study Start Date: February 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SC Methylnaltrexone (MNTX)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Women who are pregnant and/or nursing
  2. Any concurrent experimental drug therapy
  3. Evidence of fecal impaction
  4. Clinically significant active diverticular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367600

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

No publications provided

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367600     History of Changes
Other Study ID Numbers: MNTX 301EXT
Study First Received: May 27, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Advanced medical illness

Additional relevant MeSH terms:
Methylnaltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013