Compassionate Use Study of Methylnaltrexone

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. Identifier: NCT01368562
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : July 19, 2011
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment
Opioid-induced Constipation Drug: Methylnaltrexone

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects
Study Start Date : January 2003
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Drug: Methylnaltrexone

Primary Outcome Measures :
  1. Number of patients with side effects of opioid-induced constipation. [ Time Frame: 6 months ]
    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.

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

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.

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 identifier (NCT number): NCT01368562

United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc. Identifier: NCT01368562     History of Changes
Other Study ID Numbers: MNTX 901
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents