NCT04042545

Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer

SAFETY AND EFFICACY OF PPP001-kit FOR THE UNCONTROLLED PAIN RELIEF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Tetra Bio-Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.

Detailed description

This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.

Conditions

• Cancer Pain
• Quality of Life
• Pain, Acute
• Cannabis Use

Interventions

Type	Name	Description
DRUG	PPP001	1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device
DRUG	Placebo	1 placebo dosing capsule inhaled 3 times a day with a vaporizer device

Timeline

• Start date: 2020-07-30
• Primary completion: 2021-09-01
• Completion: 2022-09-01
• First posted: 2019-08-02
• Last updated: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study