drugset / Trial / NCT03337503

Safety and Efficacy of Medical Cannabis Oil in the Treatment of Patients with Chronic Pain

NCT03337503 ↗

Phase 2 Terminated 161 enrolled Santé Cannabis Tetra Bio-Pharma · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Seeking for effective therapeutic strategies, the investigators are proposing to test the effectiveness of different formulations of medical cannabis oil to alleviate chronic pain, which was partially relieved with conventional prescriptions. Furthermore, the investigators would like to assess the effect of different formulations of medical cannabis oil on other symptoms associated to chronic pain like anxiety and depression, as well as insomnia and appetite. Finally, as recently recommended for clinical studies on medical cannabis, the investigators will examine the safety profile of different cannabis formulations focusing on the following elements: a real chronic administration with more than two weeks of treatment, a larger number of patients, and the clinical relevance of medical cannabis oil to change the amount and type of concomitant medications used to control chronic non-cancer and cancer pain.

Timeline

Start
2018-01-29
Primary completion
2019-02-15
Completion
2019-02-15

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision to stop the study”

Drugs

EvaluationDrugModalityDoseRoute
Subject CBD Unknown 2.5 mg —
Subject CBD Unknown 5 mg —
Subject CBD Unknown 20 mg —
Subject THC Unknown 2.5 mg —

Indications