Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

This study has been completed.
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00672477
First received: May 2, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

Condition Intervention Phase
Opioid-Induced Constipation
Drug: Methylnaltrexone bromide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The proportion of subjects who have a rescue-free laxation response within 4 hours after at least 2 of the first 4 doses [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first rescue-free laxation [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Proportion of subjects with rescue-free laxation within 4 hours after the first dose of study drug [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Proportion of subjects with rescue-free laxation within 4 or 24 hours after each dose [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Proportion of subjects with rescue-free laxation within 4 hours after at least 4 of the maximum 7 doses [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Number of laxations per week [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Number of rescue-free laxations per week [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Time to first rescue-free laxation within 4 hours [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Time to first rescue-free laxation within 24 hours [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Time to first rescue-free laxation after each dose [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Proportion of subjects using rescue laxatives during the double-blind period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Proportion of subjects using enemas during the double-blind period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Proportion of subjects having manual disimpaction procedures performed during the double-blind period [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: June 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylnaltrexone bromide Drug: Methylnaltrexone bromide
Methylnatrexone (either 0.2ml, 0.4ml or 0.6ml) subcutaneously every other day for 14 days (ie, 7 doses)
Other Name: MOA-728
Placebo Comparator: Placebo Drug: Placebo
Placebo (either 0.2ml, 0.4ml or 0.6ml) subcutaneously every other day for 14 days (ie, 7 doses)
Other Name: Control

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is an adult 18 years of age or older
  • Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
  • Has a life expectancy of at least 1 month.
  • Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
  • Has constipation that is caused by opioid medications.

Exclusion Criteria:

  • Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
  • Has a known or suspected mechanical gastrointestinal obstruction.
  • Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
  • Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
  • Receiving opioid antagonist or partial antagonist products.
  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: NCT00672477

  Show 60 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: NCT00672477     History of Changes
Other Study ID Numbers: 3200K1-4000  B2541005 
Study First Received: May 2, 2008
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 08, 2016