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Subject registration did not proceed as expected; difficult to complete within scheduled time frame; prematurely terminated w/ 21 subjects randomized.
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Alvimopan 0.25 mg/yday | Experimental |
| |
| Alviompan 0.5 mg/day | Experimental |
| |
| Alvimopan 1 mg/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alvimopan | Drug | 0.25 mg/day |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
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| Placebo | Drug |
|
| Alvimopan 0.5 mg/day | Drug |
|
| Alvimopan 1 mg/day | Drug |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C419502 | alvimopan |
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