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

Chemotherapy Induced Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642512
• Other study ID #: S175.3.102
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2008
• Last updated: March 31, 2008
• Start date: July 2003
• Est. completion date: July 2004

Study information

• Verified date: March 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	Site 950	Anaheim	California
United States	Site 951	Arlington	Virginia
United States	Site 902	Bismarck	North Dakota
United States	Site 932	Boynton Beach	Florida
United States	Site 910	Bronx	New York
United States	Site 948	Brooklyn	New York
United States	Site 953	Brooklyn	New York
United States	Site 918	Charleston	South Carolina
United States	Site 917	Chattanooga	Tennessee
United States	Site 939	Chattanooga	Tennessee
United States	Site 944	Columbus	Ohio
United States	Site 942	Fargo	North Dakota
United States	Site 916	Fergus Falls	Minnesota
United States	Site 925	Fountain Valley	California
United States	Site 913	Greenbrae	California
United States	Site 937	Greenwood	Mississippi
United States	Site 928	Harvey	Illinois
United States	Site 924	Hollywood	Florida
United States	Site 940	Lakeland	Florida
United States	Site 919	Little Silver	New Jersey
United States	Site 909	Los Angeles	California
United States	Site 922	Marietta	Georgia
United States	Site 904	Missoula	Montana
United States	Site 923	N. Charleston	South Carolina
United States	Site 921	New Port Richey	Florida
United States	Site 929	New Port Richey	Florida
United States	Site 934	Oklahoma City	Oklahoma
United States	Site 914	Orland Park	Illinois
United States	Site 933	Ormond Beach	Florida
United States	Site 931	Philadelphia	Pennsylvania
United States	Site 906	Pittsburgh	Pennsylvania
United States	Site 908	Pomona	California
United States	Site 943	Rancho Mirage	California
United States	Site 926	Skokie	Illinois
United States	Site 905	Southfield	Michigan
United States	Site 946	Springfield	Illinois
United States	Site 958	St. Louis	Missouri
United States	Site 956	Terre Haute	Indiana
United States	Site 915	Texarkana	Texas
United States	Site 970	Tucson	Arizona
United States	Site 949	Valhalla	New York
United States	Site 920	Voorhees	New Jersey
United States	Site 947	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 days	No
Secondary	Complete responder rate (no vomiting/retching, intensity of nausea of = 30 mm on the VAS and no use of rescue medication)		5 days	No
Secondary	Presence or absence of nausea		5 days	No
Secondary	Episodes of vomiting and/or retching		5 days	No
Secondary	Duration of nausea and vomiting and/or retching		5 days	No