IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00642512
First received: March 21, 2008
Last updated: March 31, 2008
Last verified: March 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Chemotherapy Induced Nausea and Vomiting | Drug: dronabinol Drug: ondansetron Drug: dronabinol/ondansetron Drug: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Solvay Pharmaceuticals:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 64 |
| Study Start Date: | July 2003 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: dronabinol
10 - 20 mg
|
| Active Comparator: 2 |
Drug: ondansetron
8 - 16 mg
|
| 3 |
Drug: dronabinol/ondansetron
10 - 20 mg/8 - 16 mg
|
| Placebo Comparator: 4 |
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- a moderate-to-high emetogenic regimen, or
- oxaliplatin at doses employed for treatment of colon cancer, or
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642512
Show 43 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642512
Show 43 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Vickie Baranowski, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00642512 History of Changes |
| Other Study ID Numbers: |
S175.3.102 |
| Study First Received: | March 21, 2008 |
| Last Updated: | March 31, 2008 |
Keywords provided by Solvay Pharmaceuticals:
|
CINV chemotherapy nausea vomiting retching |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Ondansetron Dronabinol Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents Hallucinogens Analgesics, Non-Narcotic Analgesics Sensory System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on July 17, 2017