Status:
UNKNOWN
Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer
Lead Sponsor:
Tetra Bio-Pharma
Conditions:
Cancer Pain
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 perio...
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 r...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent,
- Adult male and female patients at least 18 years of age,
- Subject agreed to follow the protocol,
- Advanced cancer for which there is no known curative therapy as per investigator's judgement,
- Patients experiencing at least 2 symptoms related to cancer \> 4 on ESAS-r-CS NRS including pain symptom,
- Life expectancy six weeks or longer with PPS \> 50% and PaP Score Group A (30-day survival probability \>70%),
- No cognitive impairment according to Mini-Cog©,
- The patient is able to perform deep inhalations with FEV1 more than 60%,
- Ability to read and respond to questions in English,
- 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,
- 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.
Exclusion
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04042545
Start Date
July 30 2020
End Date
September 1 2022
Last Update
September 16 2021
Active Locations (1)
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1
Scottsdale Research Institute
Cave Creek, Arizona, United States, 85331