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

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:

    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

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.

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

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.

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