Study Evaluating Long-Term Safety of MOA-728 in Subjects With Opioid-Induced Constipation

Condition(s) targeted: Constipation

Intervention: N-methylnaltrexone bromide (MOA-728) (Drug)

Phase: Phase 3

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 is a one-year study to evaluate the long-term safety and tolerability of the subcutaneous (just under the skin) injection form of MOA-728 for the treatment of opioid-induced constipation in subjects with nonmalignant pain. The study consists of a 2 week screening period, a 48 week open-label treatment period and a 2 week follow-up period. Subjects will need to agree to self-administer subcutaneous injections, complete daily diaries, and check-in via a daily telephone call during that year-long period.

Official title: An Open-Label Study to Evaluate the Long-term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain

Study design: Treatment, Open Label, Single Group Assignment, Safety Study

Primary outcome: collection of safety data & assessments to include monitoring of treatment emergent adverse events, safety laboratory measurements, electrocardiograms and changes in the physical exam including vital signs while on therapy

Secondary outcome: change in bowel function compared to baseline

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

Criteria:

inclusion criteria:

1. men and women 18 years or older,

2. history of pain of at least 2 months duration before study entry due to documented underlying nonmalignant condition,

3. history of constipation due to opioid use for the nonmalignant condition, exclusion criteria:

1- diagnosis of significant GI disorder such as bowel obstruction, fecal incontinence or rectal prolapse for example, 2- history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before study entry, 3- history of malignancy or chronic constipation before initiation of opioid therapy.

Trial Manager, Email: clintrialparticipation@wyeth.com

Quebec G2B 5S1, Canada; Recruiting

Seoul 135-710, Korea, Republic of; Recruiting

Seoul 137-701, Korea, Republic of; Recruiting

Seoul 120-752, Korea, Republic of; Recruiting

Seoul 110-744, Korea, Republic of; Recruiting

Gyunggi-do 443-722, Korea, Republic of; Active, not recruiting

Madrid 28222, Spain; Active, not recruiting

Cadiz 11099, Spain; Recruiting

Barcelona 8916, Spain; Active, not recruiting

Malaga 29010, Spain; Active, not recruiting

Madrid 28006, Spain; Recruiting

Tallassee, Alabama 36078, United States; Recruiting

Mobile, Alabama 36608, United States; Recruiting

Columbiana, Alabama 35051, United States; Recruiting

Birmingham, Alabama 32542, United States; Recruiting

Edmonton, Alberta T5X 3N5, Canada; Not yet recruiting

Edmonton, Alberta T5A 4L8, Canada; Recruiting

Tucson, Arizona 85741, United States; Recruiting

Chandler, Arizona 85224, United States; Recruiting

Tempe, Arizona 85282, United States; Recruiting

Phoenix, Arizona 85029, United States; Recruiting

Tuscon, Arizona 85710, United States; Recruiting

Mesa, Arizona 85213, United States; Recruiting

Phoenix, Arizona 85028, United States; Recruiting

Mesa, Arizona 85206, United States; Recruiting

Hot Springs, Arkansas 71913, United States; Recruiting

Barranquilla, Atlantico, Colombia; Recruiting

Kelowna, British Columbia V1Y 2H4, Canada; Recruiting

Garden Grove, California 92843, United States; Recruiting

Laguna Hills, California 92653, United States; Recruiting

Newport Beach, California 92660, United States; Recruiting

Los Gatos, California 95032, United States; Recruiting

Pasadena, California 91105, United States; Recruiting

Colorado Springs, Colorado 80904, United States; Recruiting

Bogota, Cundi, Colombia; Recruiting

Winter Park, Florida 32789, United States; Completed

Brandon, Florida 33511, United States; Recruiting

Chiefland, Florida 32626, United States; Recruiting

Jacksonville, Florida 32216, United States; Recruiting

Sarasota, Florida 34239, United States; Recruiting

Tampa, Florida 33603, United States; Recruiting

Ocala, Florida 34471, United States; Recruiting

Ormond Beach, Florida 32174, United States; Recruiting

Ocala, Florida 34474, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Gainesville, Florida 32607, United States; Recruiting

Jupiter, Florida 33458, United States; Recruiting

Miami, Florida 33180, United States; Recruiting

Ft. Myers, Florida 33916, United States; Recruiting

Boca Raton, Florida 33432, United States; Recruiting

Port Orange, Florida 32129, United States; Recruiting

Tampa, Florida 33613, United States; Recruiting

Daytona Beach, Florida 32117, United States; Recruiting

Clearwater, Florida 33756, United States; Recruiting

Ocala, Florida 34471-2106, United States; Recruiting

Miami, Florida 33183, United States; Recruiting

Jacksonville, Florida 32257, United States; Recruiting

Edgewater, Florida 32132, United States; Recruiting

Vero Beach, Florida 32960, United States; Recruiting

Rockford, Illinois 61107, United States; Recruiting

Chicago, Illinois 60616, United States; Recruiting

Avon, Indiana 46123, United States; Recruiting

Indianapolis, Indiana 46250, United States; Recruiting

Indianapolis, Indiana 46205, United States; Recruiting

Evansville, Indiana 47716, United States; Recruiting

West Des Moines, Iowa 50265, United States; Recruiting

Madisonville, Kentucky 42431, United States; Recruiting

Winnipeg, Manitoba R2V 4W3, Canada; Recruiting

Hollywood, Maryland 20636, United States; Recruiting

Hagerstown, Maryland 21742, United States; Recruiting

Brockton, Massachusetts 2301, United States; Recruiting

Boston, Massachusetts 02115, United States; Recruiting

Paw Paw, Michigan 49079, United States; Recruiting

Traverse City, Michigan 49684, United States; Recruiting

Bingham Farms, Michigan 48025, United States; Recruiting

Edina, Minnesota 55435, United States; Recruiting

Jackson, Mississippi 39202, United States; Recruiting

Springfield, Missouri 65807, United States; Recruiting

Chesterfield, Missouri 48047, United States; Recruiting

Omaha, Nebraska 68131, United States; Recruiting

Las Vegas, Nevada 89119, United States; Recruiting

Las Vegas, Nevada 89146, United States; Recruiting

Henderson, Nevada 89014, United States; Recruiting

Las Vegas, Nevada 89123, United States; Recruiting

Elizabeth, New Jersey 07202, United States; Recruiting

Albuquerque, New Mexico 87102, United States; Recruiting

Broadmeadow, New South Wales 2292, Australia; Recruiting

New Lambton, New South Wales 2305, Australia; Recruiting

Great Neck, New York 11023, United States; Recruiting

New York, New York 10022, United States; Recruiting

Mount Pearl, Newfoundland and Labrador A1N 5B6, Canada; Recruiting

Charlotte, North Carolina 28204, United States; Recruiting

Raleigh, North Carolina 27607-6475, United States; Recruiting

Fargo, North Dakota 58103, United States; Recruiting

Dartmouth, Nova Scotia B2Y 1H3, Canada; Recruiting

Dayton, Ohio 45432, United States; Recruiting

Centerville, Ohio 45459, United States; Recruiting

Toronto, Ontario M9W 4L6, Canada; Recruiting

Toronto, Ontario M4T 1N5, Canada; Recruiting

Sarnia, Ontario N7T 4X3, Canada; Recruiting

Hamilton, Ontario L8M 1K7, Canada; Recruiting

London, Ontario N5Y 5K7, Canada; Recruiting

Oshawa, Ontario L1H 7K4, Canada; Recruiting

Portland, Oregon 97210, United States; Recruiting

Medford, Oregon 97504, United States; Recruiting

Levittown, Pennsylvania 19056-2404, United States; Recruiting

Altoona, Pennsylvania 16602, United States; Recruiting

Harrisburg, Pennsylvania 17112, United States; Recruiting

Yardley, Pennsylvania 19067, United States; Recruiting

St-Romuald, Quebec G6W 5M6, Canada; Recruiting

Mirabel, Quebec J7J 2K8, Canada; Recruiting

Sherbrooke, Quebec J1H 1Z1, Canada; Recruiting

Trois-Rivieres, Quebec G8T 7A1, Canada; Recruiting

Sainte-Foy, Quebec G1W 4R4, Canada; Recruiting

Cranston, Rhode Island 02920, United States; Recruiting

Huntingdon, Tennessee 38344, United States; Recruiting

Dallas, Texas 75230, United States; Recruiting

Hurst, Texas 76054, United States; Recruiting

Austin, Texas 78705, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Beaumont, Texas 77701, United States; Recruiting

Houston, Texas 77074, United States; Recruiting

San Antonio, Texas 78215, United States; Recruiting

Dallas, Texas 75324, United States; Recruiting

Salt Lake City, Utah 84106, United States; Recruiting

Christiansburg, Virginia 24073, United States; Recruiting

Bellevue, Washington 98007, United States; Completed

Starting date: December 2008
Ending date: December 2011
Last updated: September 18, 2009