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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Valeant Pharmaceuticals International, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00672139
First Posted: May 6, 2008
Last Update Posted: June 29, 2012
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.
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
  Purpose
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 Intervention Phase
Opioid-Induced Constipation Drug: Methylnaltrexone bromide Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

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

Secondary Outcome Measures:
  • No secondary endpoints [ Time Frame: No secondary endpoints ]

Estimated Enrollment: 168
Study Start Date: July 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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:

  • 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
  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): NCT00672139


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

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

Additional Information:
Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00672139     History of Changes
Other Study ID Numbers: 3200K1-4001
B2541006
First Submitted: May 2, 2008
First Posted: May 6, 2008
Last Update Posted: June 29, 2012
Last Verified: June 2012

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

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