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

Part of paid clinical trials in Cave Creek, Arizona.

Sponsor
Tetra Bio-Pharma
Study ID
NCT04042545
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PPP001 — DRUG
    1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device
  • Placebo — DRUG
    1 placebo dosing capsule inhaled 3 times a day with a vaporizer device

Study Details

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.

Key Dates

First listed
Aug 2, 2019
Start date
Jul 30, 2020
Status verified
Feb 2021
Primary completion
Sep 30, 2021
Completion
Sep 30, 2022

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: inhaled THC/CBD (PPP001)
    PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device
  • Placebo Comparator: Placebo
    Placebo inhalation with a device

Primary Outcome Measure

Uncontrolled cancer pain will be measured using a patient self-administered questionnaire. [ Time Frame: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4. ]

Central Contacts

  • Tetra Bio Pharma
    +1(438)8997575

Locations (1)

FacilityCityStateZIPSite coordinators
Scottsdale Research InstituteCave CreekArizona85331
Suzanne Sisley, MD

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By research site
Scottsdale Research Institute· Cave Creek, AZ

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