Study Evaluating the Safety of SC Methylnaltrexone in Treatment of Opioid-Induced Constipation - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00672139

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 SC 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 (OIC)	Drug: Methylnaltrexone	Phase IV

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Active Control, Single Group Assignment, Safety Study
Official Title:	Open-Label Extension Study to Assess the Safety of a Fixed Dose of Subcutaneous Methylnaltrexone in Subjects With Advanced Illness & Opioid-Induced Constipation

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Estimated Enrollment:	350
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Methylnaltrexone: Experimental	Drug: Methylnaltrexone

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

Show 69 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3200K1-4001
Study First Received:	May 2, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00672139
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Opioid-Induced Constipation treatment

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Naltrexone
Constipation
Methylnaltrexone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009