- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00642512
Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
March 31, 2008 updated by: Solvay Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States
- Site 970
-
-
California
-
Anaheim, California, United States
- Site 950
-
Fountain Valley, California, United States
- Site 925
-
Greenbrae, California, United States
- Site 913
-
Los Angeles, California, United States
- Site 909
-
Pomona, California, United States
- Site 908
-
Rancho Mirage, California, United States
- Site 943
-
-
Florida
-
Boynton Beach, Florida, United States
- Site 932
-
Hollywood, Florida, United States
- Site 924
-
Lakeland, Florida, United States
- Site 940
-
New Port Richey, Florida, United States
- Site 921
-
New Port Richey, Florida, United States
- Site 929
-
Ormond Beach, Florida, United States
- Site 933
-
-
Georgia
-
Marietta, Georgia, United States
- Site 922
-
-
Illinois
-
Harvey, Illinois, United States
- Site 928
-
Orland Park, Illinois, United States
- Site 914
-
Skokie, Illinois, United States
- Site 926
-
Springfield, Illinois, United States
- Site 946
-
-
Indiana
-
Terre Haute, Indiana, United States
- Site 956
-
-
Michigan
-
Southfield, Michigan, United States
- Site 905
-
-
Minnesota
-
Fergus Falls, Minnesota, United States
- Site 916
-
-
Mississippi
-
Greenwood, Mississippi, United States
- Site 937
-
-
Missouri
-
St. Louis, Missouri, United States
- Site 958
-
-
Montana
-
Missoula, Montana, United States
- Site 904
-
-
New Jersey
-
Little Silver, New Jersey, United States
- Site 919
-
Voorhees, New Jersey, United States
- Site 920
-
-
New York
-
Bronx, New York, United States
- Site 910
-
Brooklyn, New York, United States
- Site 948
-
Brooklyn, New York, United States
- Site 953
-
Valhalla, New York, United States
- Site 949
-
-
North Carolina
-
Wilmington, North Carolina, United States
- Site 947
-
-
North Dakota
-
Bismarck, North Dakota, United States
- Site 902
-
Fargo, North Dakota, United States
- Site 942
-
-
Ohio
-
Columbus, Ohio, United States
- Site 944
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States
- Site 934
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Site 931
-
Pittsburgh, Pennsylvania, United States
- Site 906
-
-
South Carolina
-
Charleston, South Carolina, United States
- Site 918
-
N. Charleston, South Carolina, United States
- Site 923
-
-
Tennessee
-
Chattanooga, Tennessee, United States
- Site 917
-
Chattanooga, Tennessee, United States
- Site 939
-
-
Texas
-
Texarkana, Texas, United States
- Site 915
-
-
Virginia
-
Arlington, Virginia, United States
- Site 951
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- a moderate-to-high emetogenic regimen, or
- oxaliplatin at doses employed for treatment of colon cancer, or
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
10 - 20 mg
|
Active Comparator: 2
|
8 - 16 mg
|
Placebo Comparator: 4
|
placebo
|
Other: 3
|
10 - 20 mg/8 - 16 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
5 days
|
Presence or absence of nausea
Time Frame: 5 days
|
5 days
|
Episodes of vomiting and/or retching
Time Frame: 5 days
|
5 days
|
Duration of nausea and vomiting and/or retching
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
March 21, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
April 3, 2008
Last Update Submitted That Met QC Criteria
March 31, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antiemetics
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
- Ondansetron
Other Study ID Numbers
- S175.3.102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy Induced Nausea and Vomiting
-
GlaxoSmithKlineCompletedChemotherapy-Induced Nausea and Vomiting | Nausea and Vomiting, Chemotherapy-InducedTaiwan, United States, Germany, Russian Federation, Spain, Ireland, Thailand, Hong Kong, Mexico, Philippines, Austria, Chile, Greece, Poland, Canada, Czech Republic, United Kingdom, Hungary, Pakistan, Slovakia, Singapore, Portugal, ... and more
-
Blokhin's Russian Cancer Research CenterRUSSCO/RakFondUnknownChemotherapy-induced Nausea and Vomiting | Nausea | Vomiting | Emesis | Nausea Post ChemotherapyRussian Federation
-
Otolith LabsDrexel University College of MedicineWithdrawnChemotherapy-induced Nausea and Vomiting | Nausea Post ChemotherapyUnited States
-
Indonesia UniversityMashhad University of Medical SciencesRecruitingChemotherapy-induced Nausea and Vomiting | Chemotherapy Effect | Pediatric CancerIndonesia
-
Fudan UniversityNot yet recruitingChemotherapy-induced Nausea and Vomiting | Highly Emetogenic Chemotherapy
-
Joseph MaTerminatedChemotherapy Induced Nausea Vomiting
-
Simon Williamson ClinicHelsinn Healthcare SARecruitingChemotherapy Induced Nausea and VomitingUnited States
-
University of Illinois at ChicagoRecruitingChemotherapy-induced Nausea and VomitingUnited States
-
Albert Einstein College of MedicineJacobi Medical CenterTerminatedChemotherapy-induced Nausea and VomitingUnited States
-
Purdue Pharma, CanadaCompletedChemotherapy-Induced Nausea and VomitingCanada
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States