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Study Evaluating The Safety Of Subcutaneous Methylnaltrexone In Treatment Of Opioid-Induced Constipation

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: NCT00672139
Recruitment Status : Unknown
Verified June 2012 by Valeant Pharmaceuticals International, Inc..
Recruitment status was:  Recruiting
First Posted : May 6, 2008
Last Update Posted : June 29, 2012
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

Condition or disease Intervention/treatment Phase
Opioid-Induced Constipation Drug: Methylnaltrexone bromide Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
Study Start Date : July 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Methylnaltrexone bromide Drug: Methylnaltrexone bromide
Methynaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study)

Primary Outcome Measures :
  1. Collection of adverse events, vital sign measurements, and laboratory assessments. [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. No secondary endpoints [ Time Frame: No secondary endpoints ]

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:

  • Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
  • Is receiving opioids on a regular schedule, not just as needed to control pain.
  • Likely to continue to need treatment of OIC for the duration of participation in the study.

Exclusion Criteria:

  • Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
  • Currently using an opioid antagonist or partial antagonist.
  • Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator

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): NCT00672139

Contact: Dave Mathews 919-862-1000 dave.mathews@salix.com

  Show 46 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Progenics Pharmaceuticals, Inc.
Study Director: Bob Rolleri Valeant Pharmaceuticals International, Inc.

Additional Information:
Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00672139     History of Changes
Other Study ID Numbers: 3200K1-4001
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Opioid-Induced Constipation

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