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Dose Ranging Evaluation of the Antiemetic Efficacy and Toxicity of Intramuscular Levonantradol in Cancer Subjects with Chemotherapy‐Induced Emesis
Author(s) -
STAMBAUGH JOHN E.,
McADAMS JANET,
VREELAND FRANZANNE
Publication year - 1984
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1984.tb02756.x
Subject(s) - antiemetic , medicine , toxicity , dosing , chemotherapy , anesthesia , placebo , dose ranging study , vomiting , pharmacology , double blind , alternative medicine , pathology
A phase II double‐blind placebo‐controlled, randomized dose‐ranging trial was undertaken to determine the antiemetic efficacy and toxicity of the synthetic cannabinoid levonantradol at doses of 0.5, 1.0, 1.5, and 2.0 mg. Intramuscular levonantradol was prophylactically administered in random dosing to 20 subjects with a documented history of refractory emesis due to chemotherapy in advanced cancer. The selected dose was administered prior to the chemotherapy and was serially repeated over 12 hours, and efficacy and toxicity data were evaluated for 24 hours. Significant ( P < 0.01) antiemetic activity over placebo was observed with all doses of levonantradol administered, and a dose‐effect response was not observed. Doses up to 2.0 mg were well tolerated, and observed toxicity increased with increased doses and with repeated dosing. Psychomimetic effects were mild and tolerable, and the limiting side effects were somnolence and hypotension.