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

Sponsor:	Rafa Laboratories
Collaborator:	Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by:	Rafa Laboratories
ClinicalTrials.gov Identifier:	NCT00285051

Purpose

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
Cancer	Drug: inhaled delta-8-THC	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Dizziness and Vertigo Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron delta-8-Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Rafa Laboratories:

Primary Outcome Measures:

VAS scale for nausea

Secondary Outcome Measures:

No. of emesis
VAS scale for delayed nausea
VAS scale for pain
VAS scale for appetite stimulation
VAS scale for dizziness

Estimated Enrollment:	108
Study Start Date:	November 2005
Estimated Study Completion Date:	November 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285051

Locations

Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel

Sponsors and Collaborators

Rafa Laboratories

Teva Branded Pharmaceutical Products, R&D Inc.

Investigators

Principal Investigator:

Nathan Cherny, MD

Shaare Zedek Medical Center, Dept. of Oncology

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00285051 History of Changes
Other Study ID Numbers:	Rafa protocol THC002/NVP
Study First Received:	January 31, 2006
Last Updated:	February 27, 2007
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rafa Laboratories:

emesis, nausea,

Additional relevant MeSH terms:

Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Tetrahydrocannabinol
Ondansetron
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Hallucinogens
Psychotropic Drugs

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antiemetics
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on February 09, 2012