Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

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

Status and phase: Terminated; Phase 2

Conditions: Cancer; Constipation

Treatments: Drug: Placebo; Drug: Alvimopan 0.5 mg/day; Drug: alvimopan; Drug: Alvimopan 1 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00331045

ABD102965

Details and patient eligibility

About

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Enrollment: 21 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have cancer.
• Taking opioid therapy for continued intractable pain.
• Experiencing less bowel movement frequency compared to that before the opioid treatment.
• Must meet the protocol-definition of opioid-induced constipation.

Exclusion criteria

• Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus.
• Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Alvimopan 0.25 mg/yday

Experimental group

Treatment:

Drug: alvimopan

Alviompan 0.5 mg/day

Experimental group

Treatment:

Drug: Alvimopan 0.5 mg/day

Alvimopan 1 mg/day

Experimental group

Treatment:

Drug: Alvimopan 1 mg/day