The study evaluating the efficacy, safety and economic evaluation of Thai medical marijuana products

Dr. Pongtorn Chantharatsami0 sites668 target enrollmentJuly 12, 2021

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Efficacy and safety of 2 different Thai medical marijuana products compared to placebo in palliative care patientsEconomic cost and benefit of Thai marijuana products
Sponsor: Dr. Pongtorn Chantharatsami
Enrollment: 668
Status: Not yet recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

July 12, 2021

End Date

December 1, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Dr. Pongtorn Chantharatsami

•1\. Patient with metastatic cancer or incurable cancer whom was confirmed diagnosis by histology or radiology
•2\. Patient who receives best supportive care, palliative care, or other non\-curative therapy including: palliative chemotherapy, palliative radiation therapy, targeted therapy, hormonal therapy, and palliative surgery
•3\. Patient who has symptoms or applies any medication in order to improve pain, nausea/vomiting, insomnia, or loss of appetite.
•4\. age 25 years and older
•5\. No previous medical marijuana administration at least 3 weeks prior to enrollment, if not, after stop medical marijuana at least 3 weeks, re\-inclusion will be considered.
•6\. PPS \>\= 40
•7\. For female participants in reproductive age, urine pregnancy test must be negative and contraception must be consented prior to enrollment.
•8\. For male participant, contraception must be consented and sperm donation during the study is not allowed.

•Patient who has the following:
•1\. Continuing curative therapy, including: surgery, radiation, chemotherapy
•2\. Severe symptoms of unstable cardio\-pulmonary disease, including: angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia
•3\. History of psychosis, schizophrenia, or substance use disorder (alcohol, amphetamine, cocaine, except tobacco and caffeine)
•4\. History of allergic reaction to medical marijuana product or its component
•5\. Liver impairment including: cirrhosis, or elevated liver enzyme ( AST, ALT) more than 3 times of upper normal limit
•6\. End\-stage renal disease
•7\. Pregnancy of breastfeeding woman
•8\. Taking the following medication, which has drug interaction with marijuana: warfarin, rivaroxaban, apixaban, clopidogrel, cilostazol, phenytoin, carbamazepine, phenobarbital, perampanel, propranolol, metoprolol, bisoprolol, norfloxacin, ciprofloxacin, levofloxacin, amlodipine, nifedipine, and fluoxetine
•9\. Not mindful or lack of capacity to answer questionnaires