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

Sponsor:	Salix Pharmaceuticals
Collaborator:	Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00672477

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 IV

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:

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone bromide Methylnaltrexone

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

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 recue-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
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672477

Contacts

Contact: Jeff Cohn	919-862-1000	jeff.cohn@salix.com
Contact: Dave Mathews	919-862-1000	dave.mathews@salix.com

Show 60 Study Locations

Sponsors and Collaborators

Salix Pharmaceuticals

Progenics Pharmaceuticals, Inc.

Investigators

Study Director:

Jeff Cohn

Salix Pharmaceuticals

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00672477 History of Changes
Other Study ID Numbers:	3200K1-4000, B2541005
Study First Received:	May 2, 2008
Last Updated:	January 22, 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 February 09, 2012