Clinical trial NCT00642512: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy Induced Nausea and Vomiting
Keywords: CINV
chemotherapy
nausea
vomiting
retching
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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:

  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

Primary outcomes:
measure: 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.
timeFrame: 5 days
Secondary outcomes:
measure: Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)
timeFrame: 5 days
measure: Presence or absence of nausea
timeFrame: 5 days
measure: Episodes of vomiting and/or retching
timeFrame: 5 days
measure: Duration of nausea and vomiting and/or retching
timeFrame: 5 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Site 970
state: Arizona
city: Anaheim
country: United States
facility: Site 950
state: California
city: Fountain Valley
country: United States
facility: Site 925
state: California
city: Greenbrae
country: United States
facility: Site 913
state: California
city: Los Angeles
country: United States
facility: Site 909
state: California
city: Pomona
country: United States
facility: Site 908
state: California
city: Rancho Mirage
country: United States
facility: Site 943
state: California
city: Boynton Beach
country: United States
facility: Site 932
state: Florida
city: Hollywood
country: United States
facility: Site 924
state: Florida
city: Lakeland
country: United States
facility: Site 940
state: Florida
city: New Port Richey
country: United States
facility: Site 921
state: Florida
city: New Port Richey
country: United States
facility: Site 929
state: Florida
city: Ormond Beach
country: United States
facility: Site 933
state: Florida
city: Marietta
country: United States
facility: Site 922
state: Georgia
city: Harvey
country: United States
facility: Site 928
state: Illinois
city: Orland Park
country: United States
facility: Site 914
state: Illinois
city: Skokie
country: United States
facility: Site 926
state: Illinois
city: Springfield
country: United States
facility: Site 946
state: Illinois
city: Terre Haute
country: United States
facility: Site 956
state: Indiana
city: Southfield
country: United States
facility: Site 905
state: Michigan
city: Fergus Falls
country: United States
facility: Site 916
state: Minnesota
city: Greenwood
country: United States
facility: Site 937
state: Mississippi
city: St. Louis
country: United States
facility: Site 958
state: Missouri
city: Missoula
country: United States
facility: Site 904
state: Montana
city: Little Silver
country: United States
facility: Site 919
state: New Jersey
city: Voorhees
country: United States
facility: Site 920
state: New Jersey
city: Bronx
country: United States
facility: Site 910
state: New York
city: Brooklyn
country: United States
facility: Site 948
state: New York
city: Brooklyn
country: United States
facility: Site 953
state: New York
city: Valhalla
country: United States
facility: Site 949
state: New York
city: Wilmington
country: United States
facility: Site 947
state: North Carolina
city: Bismarck
country: United States
facility: Site 902
state: North Dakota
city: Fargo
country: United States
facility: Site 942
state: North Dakota
city: Columbus
country: United States
facility: Site 944
state: Ohio
city: Oklahoma City
country: United States
facility: Site 934
state: Oklahoma
city: Philadelphia
country: United States
facility: Site 931
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 906
state: Pennsylvania
city: Charleston
country: United States
facility: Site 918
state: South Carolina
city: N. Charleston
country: United States
facility: Site 923
state: South Carolina
city: Chattanooga
country: United States
facility: Site 917
state: Tennessee
city: Chattanooga
country: United States
facility: Site 939
state: Tennessee
city: Texarkana
country: United States
facility: Site 915
state: Texas
city: Arlington
country: United States
facility: Site 951
state: Virginia
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: