Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rafa Laboratories
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Emetics; Ondansetron

Criteria

Inclusion criteria:

• Signed informed consent

• Man or woman between 18 and 85 years of age

• Patients who will be receiving at least 2 more cycles of moderately emetogenic chemotherapy

• Patients who are cognitively intact

• Performance Status of 60% or greater on the Karnofsky Scale

• Negative pregnancy test at screening visit in females of childbearing potential

• Use of appropriate contraceptive methods for females of childbearing potential during treatment (e.g. hormonal contraception, intrauterine device [IUD])

Exclusion Criteria:

• A history of psychiatric illness.

• A history of asthma and any other chronic respiratory illness.

• Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

• Serious illnesses such as asthma, diabetes mellitus, active peptic ulcer disease, infection, cardiovascular disease or any other disease which may affect the oucome parameters of this study

• Abnormal liver function tests (ALT, AST or AP > 2.5 x upper normal limit)

• Abnormal renal function (e.g. serum creatinine > 2 x upper normal limit)

• Abnormal pulmonary function test which in the judgment of the investigator is incompatible with inhalation of the study drug

• Known intolerance/hypersensitivity to study drugs (THC, ondansetron or dexamethasone) or drugs of similar chemical structure or pharmacological profile

• History of addiction to alcohol or drugs

• Existing or intended pregnancy or lactation

• Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial