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

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ClinicalTrials.gov Identifier: NCT00642512
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Nausea and Vomiting Drug: dronabinol Drug: ondansetron Drug: dronabinol/ondansetron Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : July 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: dronabinol
10 - 20 mg
Active Comparator: 2 Drug: ondansetron
8 - 16 mg
3 Drug: dronabinol/ondansetron
10 - 20 mg/8 - 16 mg
Placebo Comparator: 4 Drug: placebo
placebo



Primary Outcome Measures :
  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. [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Presence or absence of nausea [ Time Frame: 5 days ]
  3. Episodes of vomiting and/or retching [ Time Frame: 5 days ]
  4. Duration of nausea and vomiting and/or retching [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642512


  Show 43 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Vickie Baranowski, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00642512     History of Changes
Other Study ID Numbers: S175.3.102
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: March 2008

Keywords provided by Solvay Pharmaceuticals:
CINV
chemotherapy
nausea
vomiting
retching

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Dronabinol
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Hallucinogens
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists