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

Phase 3

Completed

• Conditions: Chemotherapy Induced Nausea and Vomiting
• Interventions: Drug: dronabinol/ondansetron; Drug: placebo; Drug: dronabinol; Drug: ondansetron

• Registration Number: NCT00642512
• Lead Sponsor: Solvay Pharmaceuticals

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 available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Status Verified: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-25
• Last Update Submitted: 2008-03-31
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	dronabinol/ondansetron	-
4	placebo	-
1	dronabinol	-
2	ondansetron	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (43)

Site 970; 🇺🇸 Tucson, Arizona, United States

Site 950; 🇺🇸 Anaheim, California, United States

Site 925; 🇺🇸 Fountain Valley, California, United States

Site 913; 🇺🇸 Greenbrae, California, United States

Site 909; 🇺🇸 Los Angeles, California, United States

Site 908; 🇺🇸 Pomona, California, United States

Site 943; 🇺🇸 Rancho Mirage, California, United States

Site 932; 🇺🇸 Boynton Beach, Florida, United States

Site 924; 🇺🇸 Hollywood, Florida, United States

Site 940; 🇺🇸 Lakeland, Florida, United States

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