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

Condition(s) targeted: Opioid-induced Constipation

Intervention: Methylnaltrexone (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 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.

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

Study design: Treatment, Non-Randomized, Active Control, Single Group Assignment, Safety Study

Primary outcome: Collection of adverse events, vital sign measurements, and laboratory assessments.

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

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.

Trial Manager, Email: clintrialparticipation@wyeth.com

Adelaide 5000, Australia; Recruiting

Liege B-4000, Belgium; Active, not recruiting

Leuven B-3000, Belgium; Active, not recruiting

Brussel 1090, Belgium; Not yet recruiting

Quebec G1R 2J6, Canada; Active, not recruiting

Odense 5250, Denmark; Not yet recruiting

Vejle 7100, Denmark; Not yet recruiting

Tampere 33521, Finland; Active, not recruiting

Helsinki 00029, Finland; Active, not recruiting

Munich 80336, Germany; Active, not recruiting

Aachen 52074, Germany; Active, not recruiting

Bochum 44789, Germany; Not yet recruiting

Gottingen 37075, Germany; Not yet recruiting

Berlin 14089, Germany; Active, not recruiting

Rome 00144, Italy; Recruiting

Milano 20133, Italy; Not yet recruiting

L'Aquila 67100, Italy; Active, not recruiting

Milano 20020, Italy; Not yet recruiting

Forlimpoli 47034, Italy; Not yet recruiting

Amsterdam 1007MB, Netherlands; Not yet recruiting

Nijmegen 6500HB, Netherlands; 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; Active, not recruiting

Barcelona 08036, Spain; Recruiting

Kungsbacka 43480, Sweden; Active, not recruiting

Norrkoping 60182, Sweden; Active, not recruiting

London SE26 6DZ, United Kingdom; Not yet recruiting

London SW3 6JJ, United Kingdom; Not yet recruiting

Sheffield S10 2JF, United Kingdom; Not yet recruiting

Cheltenham CL53 0QJ, United Kingdom; Not yet 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

Duarte, California 91010, United States; Not yet recruiting

Lancaster, California 93534, United States; Recruiting

San Diego, California 92103, United States; Recruiting

Laguna Hills, California 92637, United States; Recruiting

Los Angeles, California 9025, United States; Recruiting

Miami, Florida 33137, United States; Recruiting

Bay Pines, Florida 33744, United States; Not yet recruiting

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

Tempe Terrace, Florida 33637, United States; Recruiting

Besancon, Franche-Comte 25030, France; Recruiting

Lexington, Kentucky 40503, United States; Not yet recruiting

Montpellier, Languedoc-Roussilion 34295, France; Active, not recruiting

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

Boston, Massachusetts 02114, United States; Not yet recruiting

East Orange, New Jersey 07018, United States; Not yet 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

Durham, North Carolina 27710, United States; Not yet recruiting

Flat Rock, North Carolina 28731, United States; Recruiting

Winston Salem, North Carolina 27103, United States; Recruiting

Thornville, Ohio 43076, United States; Recruiting

Cleveland, Ohio 44119, United States; Recruiting

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

Hamilton, Ontario L8M 1W9, Canada; Recruiting

Philadelphia, Pennsylvania 19111, United States; Recruiting

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

Grenoble, Rhona Alpe 38043, France; Recruiting

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

Coburg, Victoria 3058, Australia; Recruiting

St Andrew's Place, Victoria 3002, Australia; Recruiting

Nedlands, Western Australia 6909, Australia; Not yet 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

Paris, ile de France 75012, France; Active, not recruiting

Starting date: June 2008
Ending date: March 2010
Last updated: July 28, 2009