Study Evaluating Subcutaneous MOA-728 For Treatment of Opioid-Induced Constipation in Patients With Advanced Illness

Condition(s) targeted: Opioid-induced Constipation

Intervention: Methylnaltrexone bromide (MOA-728) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

This study will evaluate the safety and efficacy of a subcutaneous injection of methylnaltrexone 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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The effect of the intervention will be measured by bowel movements.

Secondary outcome: Bowel movements and health outcome measures

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Is an adult 18 years of age or older

2. Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) with a life expectancy of greater than or equal to 1 month.

3. 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,

4. Has constipation that is caused by opioid medications

Exclusion Criteria:

1. Has received previous treatment with methylnaltrexone.

2. Has a known or suspected allergy to methylnaltrexone or other similar compounds (e. g. naltrexone or naloxone).

3. Has a known or suspected mechanical gastrointestinal obstruction.

4. Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.

5. 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.

6. Receiving opioid antagonist or partial antagonist products

Trial Manager, Email: clintrialparticipation@wyeth.com

Liege B-4000, Belgium; Active, not recruiting

Leuven B-3000, Belgium; Recruiting

Gent 9000, Belgium; Active, not recruiting

Quebec G1R 2J6, Canada; Active, not recruiting

Tampere 33521, Finland; Active, not recruiting

Helsinki 00029, Finland; Active, not recruiting

Paris 75012, France; Active, not recruiting

Munich 80336, Germany; Active, not recruiting

Aachen 52074, Germany; Recruiting

Bochum 44789, Germany; Withdrawn

Berlin 14089, Germany; Active, not recruiting

Rome 00144, Italy; Not yet recruiting

Milano 20133, Italy; Active, not recruiting

L'Aquila 67100, Italy; Recruiting

Milano 20020, Italy; Active, not recruiting

Forlimpoli 47034, Italy; Not yet recruiting

Bergen 5892, Norway; Active, not recruiting

Almada 2801-951, Portugal; Active, not recruiting

Porto 4200-072, Portugal; Active, not recruiting

Sevilla 41013, Spain; Active, not recruiting

Castellon de la Plana 12002, Spain; Active, not recruiting

L'Hospitalet-Barcelona 08907, Spain; Recruiting

Barcelona 08036, Spain; Recruiting

Kungsbacka 43480, Sweden; Recruiting

Norrkoping 60182, Sweden; Recruiting

London SE26 6DZ, United Kingdom; Active, not recruiting

London SW3 6JJ, United Kingdom; Active, not recruiting

Sheffield S10 2JF, United Kingdom; Active, not recruiting

Cheltenham CL53 0QJ, United Kingdom; Recruiting

Tuscaloosa, Alabama 35406, United States; Recruiting

Demopolis, Alabama 36732, United States; Recruiting

Mobile, Alabama 36604, United States; Recruiting

Edmonton, Alberta T6L 5X8, Canada; Active, not recruiting

Bordeaux, Aquitaine 33075, France; Active, not recruiting

Surrey, British Columbia V3T 5T3, Canada; Active, not recruiting

Lancaster, California 93534, United States; Recruiting

San Diego, California 92103, United States; Recruiting

Laguna Hills, California 92637, United States; Recruiting

Los Angeles, California 90025, United States; Recruiting

Sonoma, California 95476, United States; Recruiting

Miami, Florida 33137, United States; Terminated

Miami Springs, Florida 33166, United States; Recruiting

Tampa, Florida 33612, United States; Recruiting

West Palm Beach, Florida 33407, United States; Recruiting

Hudson, Florida 34667, United States; Completed

Tampa, Florida 33609, United States; Recruiting

Besancon, Franche-Comte 25030, France; Recruiting

Montpellier, Languedoc-Roussillion 34295, France; Recruiting

Winnipeg, Manitoba R2H 2A6, Canada; Active, not recruiting

Northwood, Middlesex HA6 2RN, United Kingdom; Active, not recruiting

Henderson, Nevada 89014, United States; Recruiting

Albuguerque, New Mexico 87108, United States; Recruiting

Albequerque, New Mexico 87108, United States; Recruiting

Darlinghurst, New South Wales 2010, Australia; Not yet recruiting

New York, New York 10032, United States; Recruiting

New York, New York 10021, United States; Terminated

Durham, North Carolina 27710, United States; Recruiting

Flat Rock, North Carolina 28731, United States; Recruiting

Winston Salem, North Carolina 27103, United States; Recruiting

Thornville, Ohio 43076, United States; Terminated

Cleveland, Ohio 44119, United States; Recruiting

Hamilton, Ontario L8M 1W9, Canada; Recruiting

Hamilton, Ontario L8M 1W9, Canada; Active, not recruiting

London, Ontario N6A 4L6, Canada; Active, not recruiting

Philadelphia, Pennsylvania 19111, United States; Recruiting

Montreal, Quebec H3A 1A!, Canada; Active, not recruiting

Montreal, Quebec H3T 1E2, Canada; Active, not recruiting

Grenoble, Rhona Alpe 38043, France; Recruiting

Pierre-Benite, Rhone Alpe 69495, France; Active, not recruiting

Adelaide, South Australia 5000, Australia; Recruiting

Sutton, Surrey SM2 5PT, United Kingdom; Active, not recruiting

Austin, Texas 78757, United States; Recruiting

Houston, Texas 77030, United States; Not yet recruiting

Orem, Utah 84058, United States; Recruiting

American Fork, Utah 84003, United States; Recruiting

Coburg, Victoria 3058, Australia; Recruiting

East Melbourne, Victoria 3002, Australia; Recruiting

Madison, Wisconsin 53792, United States; Recruiting

Paris, ile de France 75248, France; Active, not recruiting

Puteaux, ile de France 92800, France; Active, not recruiting

Boulogne-Billancourt, ile de France 92100, France; Active, not recruiting

Paris, ile de France 75181, France; Active, not recruiting

Villejuif, ile de France 94804, France; Recruiting

Starting date: May 2008
Ending date: January 2010
Last updated: October 13, 2009