Compassionate Use Study of Methylnaltrexone

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01368562
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
  Purpose

This is an open label compassionate use study of subcutaneously administered MNTX in subjects with advance medical illness and opioid-induced constipation. Eligible subjects were to initially receive a single dose of MNTX delivered SC. Subsequent dosing could have been adjusted upward to achieve a desired clinical response or lowered to alleviate drug related adverse events (AEs).


Condition Intervention
Opioid-induced Constipation
Drug: Methylnaltrexone

Salix Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Number of patients with side effects of opioid-induced constipation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To provide subcutaneously administered MNTX to advanced medical illness patients on a compassionate basis in order to alleviate the side effects of opioid-induced constipation.


Enrollment: 26
Study Start Date: January 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Methylnaltrexone
Drug: Methylnaltrexone
SC

  Eligibility

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

Inclusion Criteria:

  1. Advanced medical illness (i.e. terminal illness, such as incurable cancer or end stage AIDS) with a life expectancy of one to six months
  2. On an opioid regimen for the control of pain/discomfort for at least seven days
  3. Has opioid-induced constipation
  4. On a laxative regimen (e.g. stool softener and SENNA or equivalent) for at least 3 days prior to treatment.

Exclusion Criteria:

  1. Patients with known hypersensitivity to methylnaltrexone, naltrexone or naloxone
  2. Patients who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction
  3. Patients who are constipated and have active, clinically significant diverticulitis
  4. Patients being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure
  5. Individuals with a known drug addiction.
  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: NCT01368562

Locations
United States, New York
Progenics Pharmaceuticals, Inc.
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, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01368562     History of Changes
Other Study ID Numbers: MNTX 901
Study First Received: May 27, 2011
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Methylnaltrexone
Naltrexone
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 August 26, 2014