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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-

Conditions
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Cancer, Constipation

Intervention / Treatment
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* Drug: alvimopan
* Drug: Placebo
* Drug: Alvimopan 0.5 mg/day
* Drug: Alvimopan 1 mg/day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: Alvimopan 0.25 mg/yday<br> | Drug: alvimopan<br>* 0.25 mg/day<br>* Other names: SB767905;|
| Experimental: Alviompan 0.5 mg/day<br> | Drug: Alvimopan 0.5 mg/day<br> <br> |
| Experimental: Alvimopan 1 mg/day<br> | Drug: Alvimopan 1 mg/day<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, cancer, constipation