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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00642512
First received: March 21, 2008
Last updated: March 31, 2008
Last verified: March 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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
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

  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

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

No publications provided

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

Keywords provided by Solvay Pharmaceuticals:
CINV
chemotherapy
nausea
vomiting
retching

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Tetrahydrocannabinol
Ondansetron
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 16, 2013