Recruiting
Phase 2

Inhaled Cannabis

Sponsor:

Tetra Bio-Pharma

Code:

NCT04042545

Conditions

Cancer Pain

Quality of Life

Pain, Acute

Cannabis Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PPP001

Placebo

Study Details

Brief 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

Study ID

NCT04042545

Start date

Jul 30, 2020

Status verified date

Feb, 2021

Completion date

Sep, 2022

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Written informed consent,
2. Adult male and female patients at least 18 years of age,
3. Subject agreed to follow the protocol,
4. Advanced cancer for which there is no known curative therapy as per investigator's judgement,
5. Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom,
6. Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%),
7. No cognitive impairment according to Mini-Cog©,
8. The patient is able to perform deep inhalations with FEV1 more than 60%,
9. Ability to read and respond to questions in English,
10. A female volunteer must meet one of the following criteria:

If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose, If of non-childbearing potential - should be surgically sterile or in a menopausal state,
11. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

PPP001

1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device

Placebo

1 placebo dosing capsule inhaled 3 times a day with a vaporizer 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 and Locations

Central contacts

Tetra Bio Pharma

+1(438)8997575

Locations

Scottsdale Research Institute

Recruiting

Cave Creek, Arizona, United States, 85331

More Information

Sponsor

Tetra Bio-Pharma

Last update posted

Sep 16, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tetra Bio-Pharma on 2021-09-16.