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Trial record 1 of 1 for:    delta-8
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Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00285051
Recruitment Status : Suspended (Study drug expiry date not extended)
First Posted : February 1, 2006
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by:
Rafa Laboratories

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 1, 2006
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
VAS scale for nausea
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
  • No. of emesis
  • VAS scale for delayed nausea
  • VAS scale for pain
  • VAS scale for appetite stimulation
  • VAS scale for dizziness
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
Official Title  ICMJE 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
Brief 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Drug: inhaled delta-8-THC
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Enrollment  ICMJE
 (submitted: January 31, 2006)
108
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285051
Other Study ID Numbers  ICMJE Rafa protocol THC002/NVP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rafa Laboratories
Collaborators  ICMJE Teva Branded Pharmaceutical Products R&D, Inc.
Investigators  ICMJE
Principal Investigator: Nathan Cherny, MD Shaare Zedek Medical Center, Dept. of Oncology
PRS Account Rafa Laboratories
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP