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
  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:


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
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: 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
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014