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

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

Status and phase: Completed; Phase 2

Conditions: Constipation; Bowel Dysfunction

Treatments: Drug: placebo; Drug: alvimopan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00101998

3753-009

767905/008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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233 participants in 4 patient groups, including a placebo group

Alvimopan 0.5 mg Twice Daily (BID)

Experimental group

Description:

0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.

Treatment:

Drug: alvimopan

Alvimopan 1 mg Once Daily (QD)

Experimental group

Description:

0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.

Treatment:

Drug: placebo

Drug: alvimopan

Alvimopan 1 mg Twice Daily (BID)

Experimental group

Description:

0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Treatment:

Drug: alvimopan

Placebo

Placebo Comparator group

Description:

Placebo was administered orally BID for 3 weeks.

Treatment:

Drug: placebo