Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting
1 other identifier
interventional
64
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2003
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedApril 3, 2008
March 1, 2008
1 year
March 21, 2008
March 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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
Episodes of vomiting and/or retching
5 days
Duration of nausea and vomiting and/or retching
5 days
Study Arms (4)
1
EXPERIMENTAL2
ACTIVE COMPARATOR3
OTHER4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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:
- a moderate-to-high emetogenic regimen, or
- oxaliplatin at doses employed for treatment of colon cancer, or
- the combination of AC \[AdriamycinĂ’ (60 mg/m2) with cyclophosphamide (600 mg/m2)\] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.
You may not qualify if:
- Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 25, 2008
Study Start
July 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
April 3, 2008
Record last verified: 2008-03