Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
NCT ID: NCT00642512
Last Updated: 2008-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2003-07-31
2004-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
dronabinol
10 - 20 mg
2
ondansetron
8 - 16 mg
3
dronabinol/ondansetron
10 - 20 mg/8 - 16 mg
4
placebo
placebo
Interventions
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dronabinol
10 - 20 mg
ondansetron
8 - 16 mg
dronabinol/ondansetron
10 - 20 mg/8 - 16 mg
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
1. a moderate-to-high emetogenic regimen, or
2. oxaliplatin at doses employed for treatment of colon cancer, or
3. the combination of AC \[AdriamycinÒ (60 mg/m2) with cyclophosphamide (600 mg/m2)\] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.
Exclusion Criteria
* Chemotherapy agents falling into the high (Level 5) classification during study.
* Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
18 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 970
Tucson, Arizona, United States
Site 950
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
Countries
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Other Identifiers
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S175.3.102
Identifier Type: -
Identifier Source: org_study_id