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

This study is currently recruiting participants.
Verified June 2012 by Salix Pharmaceuticals
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00672139
First received: May 2, 2008
Last updated: June 27, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 Salix Pharmaceuticals:

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

Secondary Outcome Measures:
  • No secondary endpoints [ Time Frame: No secondary endpoints ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672139

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

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

Additional Information:
No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00672139     History of Changes
Other Study ID Numbers: 3200K1-4001, B2541006
Study First Received: May 2, 2008
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Opioid-Induced Constipation

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

ClinicalTrials.gov processed this record on April 21, 2014