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

Primary Purpose

Chemotherapy Induced Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
dronabinol
ondansetron
dronabinol/ondansetron
placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy Induced Nausea and Vomiting focused on measuring CINV, chemotherapy, nausea, vomiting, retching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 970
  • Site 950
  • Site 925
  • Site 913
  • Site 909
  • Site 908
  • Site 943
  • Site 932
  • Site 924
  • Site 940
  • Site 921
  • Site 929
  • Site 933
  • Site 922
  • Site 928
  • Site 914
  • Site 926
  • Site 946
  • Site 956
  • Site 905
  • Site 916
  • Site 937
  • Site 958
  • Site 904
  • Site 919
  • Site 920
  • Site 910
  • Site 948
  • Site 953
  • Site 949
  • Site 947
  • Site 902
  • Site 942
  • Site 944
  • Site 934
  • Site 931
  • Site 906
  • Site 918
  • Site 923
  • Site 917
  • Site 939
  • Site 915
  • Site 951

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Other

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

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.

Secondary Outcome Measures

Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)
Presence or absence of nausea
Episodes of vomiting and/or retching
Duration of nausea and vomiting and/or retching

Full Information

First Posted
March 21, 2008
Last Updated
March 31, 2008
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00642512
Brief Title
Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
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 Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Nausea and Vomiting
Keywords
CINV, chemotherapy, nausea, vomiting, retching

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Other
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dronabinol
Intervention Description
10 - 20 mg
Intervention Type
Drug
Intervention Name(s)
ondansetron
Intervention Description
8 - 16 mg
Intervention Type
Drug
Intervention Name(s)
dronabinol/ondansetron
Intervention Description
10 - 20 mg/8 - 16 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Presence or absence of nausea
Time Frame
5 days
Title
Episodes of vomiting and/or retching
Time Frame
5 days
Title
Duration of nausea and vomiting and/or retching
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 970
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 950
City
Anaheim
State/Province
California
Country
United States
Facility Name
Site 925
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Site 913
City
Greenbrae
State/Province
California
Country
United States
Facility Name
Site 909
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 908
City
Pomona
State/Province
California
Country
United States
Facility Name
Site 943
City
Rancho Mirage
State/Province
California
Country
United States
Facility Name
Site 932
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Site 924
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Site 940
City
Lakeland
State/Province
Florida
Country
United States
Facility Name
Site 921
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Site 929
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Site 933
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Site 922
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Site 928
City
Harvey
State/Province
Illinois
Country
United States
Facility Name
Site 914
City
Orland Park
State/Province
Illinois
Country
United States
Facility Name
Site 926
City
Skokie
State/Province
Illinois
Country
United States
Facility Name
Site 946
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Site 956
City
Terre Haute
State/Province
Indiana
Country
United States
Facility Name
Site 905
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
Site 916
City
Fergus Falls
State/Province
Minnesota
Country
United States
Facility Name
Site 937
City
Greenwood
State/Province
Mississippi
Country
United States
Facility Name
Site 958
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 904
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Site 919
City
Little Silver
State/Province
New Jersey
Country
United States
Facility Name
Site 920
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Site 910
City
Bronx
State/Province
New York
Country
United States
Facility Name
Site 948
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Site 953
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Site 949
City
Valhalla
State/Province
New York
Country
United States
Facility Name
Site 947
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Site 902
City
Bismarck
State/Province
North Dakota
Country
United States
Facility Name
Site 942
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
Site 944
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Site 934
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 931
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 906
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Site 918
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Site 923
City
N. Charleston
State/Province
South Carolina
Country
United States
Facility Name
Site 917
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Site 939
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Site 915
City
Texarkana
State/Province
Texas
Country
United States
Facility Name
Site 951
City
Arlington
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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

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