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”

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 Type: Interventional

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

Study Primary Completion Date: July 2004

Intervention(s) in this Clinical Trial

• Drug: dronabinol
  • 10 - 20 mg
• Drug: ondansetron
  • 8 - 16 mg
• Drug: dronabinol/ondansetron
  • 10 - 20 mg/8 - 16 mg
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Other: 3
• Placebo Comparator: 4

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Presence or absence of nausea
  • Time Frame: 5 days
    Safety Issue?: No
• Episodes of vomiting and/or retching
  • Time Frame: 5 days
    Safety Issue?: No
• Duration of nausea and vomiting and/or retching
  • Time Frame: 5 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642512

Study ID Number: S175.3.102

ClinicalTrials.gov Identifier: NCT00642512

Health Authority: United States: Food and Drug Administration