Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00642512

Purpose

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.

Condition	Intervention	Phase
Chemotherapy Induced Nausea and Vomiting	Drug: dronabinol Drug: ondansetron Drug: dronabinol/ondansetron Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

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. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Presence or absence of nausea [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Episodes of vomiting and/or retching [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Duration of nausea and vomiting and/or retching [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	July 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: dronabinol 10 - 20 mg
2: Active Comparator	Drug: ondansetron 8 - 16 mg
3	Drug: dronabinol/ondansetron 10 - 20 mg/8 - 16 mg
4: Placebo Comparator	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:
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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642512

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Locations

United States, Arizona
Site 970
Tucson, Arizona, United States
United States, California
Site 908
Pomona, California, United States
Site 909
Los Angeles, California, United States
Site 913
Greenbrae, California, United States
Site 925
Fountain Valley, California, United States
Site 943
Rancho Mirage, California, United States
Site 950
Anaheim, California, United States
United States, Florida
Site 921
New Port Richey, Florida, United States
Site 924
Hollywood, Florida, United States
Site 929
New Port Richey, Florida, United States
Site 932
Boynton Beach, Florida, United States
Site 933
Ormond Beach, Florida, United States
Site 940
Lakeland, Florida, United States
United States, Georgia
Site 922
Marietta, Georgia, United States
United States, Illinois
Site 914
Orland Park, Illinois, United States
Site 926
Skokie, Illinois, United States
Site 928
Harvey, Illinois, United States
Site 946
Springfield, Illinois, United States
United States, Indiana
Site 956
Terre Haute, Indiana, United States
United States, Michigan
Site 905
Southfield, Michigan, United States
United States, Minnesota
Site 916
Fergus Falls, Minnesota, United States
United States, Mississippi
Site 937
Greenwood, Mississippi, United States
United States, Missouri
Site 958
St. Louis, Missouri, United States
United States, Montana
Site 904
Missoula, Montana, United States
United States, New Jersey
Site 919
Little Silver, New Jersey, United States
Site 920
Voorhees, New Jersey, United States
United States, New York
Site 910
Bronx, New York, United States
Site 948
Brooklyn, New York, United States
Site 949
Valhalla, New York, United States
Site 953
Brooklyn, New York, United States
United States, North Carolina
Site 947
Wilmington, North Carolina, United States
United States, North Dakota
Site 902
Bismarck, North Dakota, United States
Site 942
Fargo, North Dakota, United States
United States, Ohio
Site 944
Columbus, Ohio, United States
United States, Oklahoma
Site 934
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Site 906
Pittsburgh, Pennsylvania, United States
Site 931
Philadelphia, Pennsylvania, United States
United States, South Carolina
Site 918
Charleston, South Carolina, United States
Site 923
N. Charleston, South Carolina, United States
United States, Tennessee
Site 917
Chattanooga, Tennessee, United States
Site 939
Chattanooga, Tennessee, United States
United States, Texas
Site 915
Texarkana, Texas, United States
United States, Virginia
Site 951
Arlington, Virginia, United States

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Vickie Baranowski )
Study ID Numbers:	S175.3.102
Study First Received:	March 21, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00642512 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

CINV
chemotherapy
nausea
vomiting
retching

Additional relevant MeSH terms:

Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Hallucinogens
Antiemetics
Signs and Symptoms
Serotonin Antagonists
Sensory System Agents
Therapeutic Uses
Antipruritics
Nausea
Ondansetron

Analgesics
Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Tetrahydrocannabinol
Serotonin Agents
Analgesics, Non-Narcotic
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009