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Open-Label Treatment Extension of Protocol MNTX 301

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.
ClinicalTrials.gov Identifier: NCT01367600
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 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 301
Study Start Date : February 2003
Primary Completion Date : February 2005
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: SC Methylnaltrexone (MNTX)


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 3 months ]
    To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.


Secondary Outcome Measures :
  1. Change from baseline in pain scores [ Time Frame: 3 months ]
    To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

  2. Number of patients with opioid withdrawal symptoms [ Time Frame: 3 months ]
    To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.


Eligibility Criteria

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. 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

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): NCT01367600


Locations
United States, New York
Progenics Pharmaceuticals
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: NCT01367600     History of Changes
Other Study ID Numbers: MNTX 301EXT
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