Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
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| ClinicalTrials.gov Identifier: NCT00642512 |
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Recruitment Status :
Completed
First Posted : March 25, 2008
Last Update Posted : April 3, 2008
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Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chemotherapy Induced Nausea and Vomiting | Drug: dronabinol Drug: ondansetron Drug: dronabinol/ondansetron Drug: placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (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 |
| Study Start Date : | July 2003 |
| Actual Primary Completion Date : | July 2004 |
| Actual Study Completion Date : | July 2004 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Nausea and Vomiting
| Arm | Intervention/treatment |
|---|---|
| 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 |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642512
Locations
Show 43 study locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
| Responsible Party: | Vickie Baranowski, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00642512 |
| Other Study ID Numbers: |
S175.3.102 |
| First Posted: | March 25, 2008 Key Record Dates |
| Last Update Posted: | April 3, 2008 |
| Last Verified: | March 2008 |
Keywords provided by Solvay Pharmaceuticals:
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CINV chemotherapy nausea vomiting retching |
Additional relevant MeSH terms:
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Nausea Vomiting Signs and Symptoms, Digestive Dronabinol Ondansetron 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 |