MedTrace Logo

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

NCT00642512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2008-04-03

No results posted yet for this study

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

DRUG

dronabinol

10 - 20 mg

DRUG

ondansetron

8 - 16 mg

DRUG

dronabinol/ondansetron

10 - 20 mg/8 - 16 mg

DRUG

placebo

placebo

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2004-07-31
Completion
2004-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642512 on ClinicalTrials.gov