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

NCT04042545 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Tetra Bio-Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-09-30
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042545 on ClinicalTrials.gov