NCT00642512

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	dronabinol	10 - 20 mg
DRUG	ondansetron	8 - 16 mg
DRUG	dronabinol/ondansetron	10 - 20 mg/8 - 16 mg
DRUG	placebo	placebo

Timeline

• Start date: 2003-07-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2008-03-25
• Last updated: 2008-04-03

Locations

43 sites across 1 country: United States