Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Completed · Phase 2 · Has a placebo group

Conditions studied: Constipation, Bowel Dysfunction

In brief

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Key facts

Study ID

NCT00101998

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

233

Starts

2003-10-01

Expected to finish

2006-05-01

Last updated by the study team

2017-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
• Participant is taking opioid therapy for persistent cancer pain.
• Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].
• Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
• Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

You may not qualify if…

• Participant is pregnant or lactating, or planning to become pregnant.
• Participant is not ambulatory.
• Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
• Participant is unable to eat, drink, take/hold down oral medications.
• Participant is taking opioids for the management of drug addiction.
• Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
• Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
• Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
• Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
• Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
• Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Where it is running

• GSK Investigational Site — Hot Springs, Arkansas, United States
• GSK Investigational Site — Duarte, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — La Verne, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Gatos, California, United States
• GSK Investigational Site — Modesto, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Inverness, Florida, United States
• GSK Investigational Site — Lecanto, Florida, United States
• GSK Investigational Site — Miami Shores, Florida, United States
• GSK Investigational Site — New Port Richey, Florida, United States
• GSK Investigational Site — New Port Richey, Florida, United States
• GSK Investigational Site — Ocala, Florida, United States
• GSK Investigational Site — Palm Harbor, Florida, United States
• GSK Investigational Site — Stuart, Florida, United States
• GSK Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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