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The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Other |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dronabinol | Drug | 10 - 20 mg |
| |
| ondansetron |
| Measure | Description | Time Frame |
|---|---|---|
| Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication) | 5 days | |
| Presence or absence of nausea | 5 days | |
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Inclusion Criteria:
Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 970 | Tucson | Arizona | United States | |||
| Site 950 |
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| Drug |
8 - 16 mg |
|
| dronabinol/ondansetron | Drug | 10 - 20 mg/8 - 16 mg |
|
| placebo | Drug | placebo |
|
| Episodes of vomiting and/or retching |
| 5 days |
| Duration of nausea and vomiting and/or retching | 5 days |
| Anaheim |
| California |
| United States |
| Site 925 | Fountain Valley | California | United States |
| Site 913 | Greenbrae | California | United States |
| Site 909 | Los Angeles | California | United States |
| Site 908 | Pomona | California | United States |
| Site 943 | Rancho Mirage | California | United States |
| Site 932 | Boynton Beach | Florida | United States |
| Site 924 | Hollywood | Florida | United States |
| Site 940 | Lakeland | Florida | United States |
| Site 921 | New Port Richey | Florida | United States |
| Site 929 | New Port Richey | Florida | United States |
| Site 933 | Ormond Beach | Florida | United States |
| Site 922 | Marietta | Georgia | United States |
| Site 928 | Harvey | Illinois | United States |
| Site 914 | Orland Park | Illinois | United States |
| Site 926 | Skokie | Illinois | United States |
| Site 946 | Springfield | Illinois | United States |
| Site 956 | Terre Haute | Indiana | United States |
| Site 905 | Southfield | Michigan | United States |
| Site 916 | Fergus Falls | Minnesota | United States |
| Site 937 | Greenwood | Mississippi | United States |
| Site 958 | St Louis | Missouri | United States |
| Site 904 | Missoula | Montana | United States |
| Site 919 | Little Silver | New Jersey | United States |
| Site 920 | Voorhees Township | New Jersey | United States |
| Site 948 | Brooklyn | New York | United States |
| Site 953 | Brooklyn | New York | United States |
| Site 910 | The Bronx | New York | United States |
| Site 949 | Valhalla | New York | United States |
| Site 947 | Wilmington | North Carolina | United States |
| Site 902 | Bismarck | North Dakota | United States |
| Site 942 | Fargo | North Dakota | United States |
| Site 944 | Columbus | Ohio | United States |
| Site 934 | Oklahoma City | Oklahoma | United States |
| Site 931 | Philadelphia | Pennsylvania | United States |
| Site 906 | Pittsburgh | Pennsylvania | United States |
| Site 918 | Charleston | South Carolina | United States |
| Site 923 | North Charleston | South Carolina | United States |
| Site 917 | Chattanooga | Tennessee | United States |
| Site 939 | Chattanooga | Tennessee | United States |
| Site 915 | Texarkana | Texas | United States |
| Site 951 | Arlington | Virginia | United States |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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