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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Conditions
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Cancer, Bowel Dysfunction

Intervention / Treatment
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* Drug: alvimopan
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alvimopan 0.5 mg Twice Daily (BID)<br>0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening. | Drug: alvimopan<br> <br> |
| Experimental: Alvimopan 1 mg Once Daily (QD)<br>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. | Drug: alvimopan<br> <br> Drug: placebo<br> <br> |
| Experimental: Alvimopan 1 mg Twice Daily (BID)<br>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. | Drug: alvimopan<br> <br> |
| Placebo Comparator: Placebo<br>Placebo was administered orally once in the morning and once in evening. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of reported adverse events, including serious adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, constipation, opioid-induced bowel dysfunction