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

This study has been completed.

Sponsor:

Information provided by:

Solvay Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00642512

First received: March 21, 2008

Last updated: March 31, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2008

Last Updated Date

March 31, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

July 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 5 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00642512 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Chemotherapy Induced Nausea and Vomiting

Intervention ^ICMJE

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

Study Arms

Experimental: 1
Intervention: Drug: dronabinol
Active Comparator: 2
Intervention: Drug: ondansetron
3
Intervention: Drug: dronabinol/ondansetron
Placebo Comparator: 4
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

July 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00642512

Other Study ID Numbers ^ICMJE

S175.3.102

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Vickie Baranowski, Solvay Pharmaceuticals

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

PRS Account

Solvay Pharmaceuticals

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top