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Sponsors and Collaborators: |
Rafa Laboratories IVAX Research LLC |
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Information provided by: | Rafa Laboratories |
ClinicalTrials.gov Identifier: | NCT00285051 |
Patients will be treated for 2 consecutive chemo cycles with the study drug for one and placebo for the other. In addition, patients will receive an injection before the chemo, either ondansetron (if receiving placebo inhalation) or normal saline) if receiving active study drug. They will take study medication for 3 days, 4 times daily and fill out VAS scores before and after doses. Patients will be given rescue medication with each dose.
Condition | Intervention | Phase |
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Cancer |
Drug: inhaled delta-8-THC |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Study to Compare the Safety and Efficacy of 2 Different Doses of Inhaled D8-THC to Standard Therapy With Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy |
Estimated Enrollment: | 108 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2005 |
The study is comparing the use of inhaled delata-8-THC in the prevention of nausea and vomitting in patients being treated with moderately emetogenic chemotherapy, and the patients will continue use for 3 days afterward. Patients will be given rescue medication and will fill out VAS scales for nausea, pain, appetite and dizziness. Patients will be treated for 2 cycles, one cycle receiving active drug (one of 2 doses) and the other placebo. Patients receiving placebo will receive ondansetron injection before chemo and patients receiving active drug will receive a normal saline injection. Patients will take the drug 4 times daily for 3 days. The patients will return to clinic for a visit after 24-48 hours and 4 days. Patients will bring a urine sample to measure metabolite. Patients will be given a diary to monitor dosing and side effects as well as concomitant medication. The study will be conducted in 2 - 3 centers. There will be 108 patients enrolled with 27 in each of 4 groups:
Group 1 cycle 1 - Placebo cycle 2 - 300 mcg of delta-8-THC per dose Group 2 cycle 1 - Placebo cycle 2 - 600 mcg of delta-8-THC per dose Group 3 cycle 1 - 300 mcg of delta-8-THC per doseGroup cycle 2 - Placebo Group 4 cycle 1 - 600 mcg of delta-8-THC per dose cycle 2 - placebo
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Israel | |
Shaare Zedek Medical Center | |
Jerusalem, Israel | |
Chaim Sheba Medical Center | |
Tel Hashomer, Israel |
Principal Investigator: | Nathan Cherny, MD | Shaare Zedek Medical Center, Dept. of Oncology |
Study ID Numbers: | Rafa protocol THC002/NVP |
Study First Received: | January 31, 2006 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00285051 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
emesis, nausea, |
Vomiting Nausea Ondansetron Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |