Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

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

Status and phase: Completed; Phase 2

Conditions: Cancer; Bowel Dysfunction

Treatments: Drug: alvimopan; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135577

ABD101684

Details and patient eligibility

About

Study SB-767905/008 was 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 participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008.
• Taking full agonist opioid therapy for cancer related pain.
• Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD.
• Capable of completing paper questionnaires at the study visits.

Exclusion criteria

• Unable to eat or drink.
• Taking opioids for management of drug addiction.
• Unable to use only rescue laxatives provided.
• Inappropriately managed severe constipation that puts subject at risk of complications.
• Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit.
• Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

67 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 once in the morning and once in the evening.

Treatment:

Drug: alvimopan

Alvimopan 1 mg Once Daily (QD)

Experimental group

Description:

Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks.

Treatment:

Drug: placebo

Drug: alvimopan

Alvimopan 1 mg Twice Daily (BID)

Experimental group

Description:

Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening.

Treatment:

Drug: alvimopan

Placebo

Placebo Comparator group

Description:

Placebo was administered orally once in the morning and once in evening.

Treatment:

Drug: placebo