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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00642512

Enrollment

Registered

2008-03-25

Start date

2003-07-31

Completion date

2004-07-31

Last updated

2008-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Induced Nausea and Vomiting

Keywords

CINV, chemotherapy, nausea, vomiting, retching

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.

Interventions

DRUGdronabinol

10 - 20 mg

DRUGondansetron

8 - 16 mg

DRUGdronabinol/ondansetron

10 - 20 mg/8 - 16 mg

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)	5 days
Presence or absence of nausea	5 days
Episodes of vomiting and/or retching	5 days
Duration of nausea and vomiting and/or retching	5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026