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PPP001 for Acute Pain (PLENITUDE Trial)

Phase 2
Waitlist Available
Research Sponsored by Tetra Bio-Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in the eortc-qlq-c15-pal pain multi-item scale score at week 4.
Awards & highlights

PLENITUDE Trial Summary

This trial is testing a new drug to see if it is safe and effective at relieving pain in advanced cancer patients who have not had relief from other treatments. The trial will last for 1 year.

Eligible Conditions
  • Acute Pain
  • Cancer Pain
  • Quality of Life
  • Cannabis Use

PLENITUDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in the eortc-qlq-c15-pal pain multi-item scale score at week 4.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in the eortc-qlq-c15-pal pain multi-item scale score at week 4. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
Secondary outcome measures
The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire
The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms related to advanced cancer will be measured using a patient self rating questionnaire.
The palliative performance scale will be scored by a healthcare profesional.
+2 more

PLENITUDE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: inhaled THC/CBD (PPP001)Experimental Treatment1 Intervention
PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device
Group II: PlaceboPlacebo Group1 Intervention
Placebo inhalation with a device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PPP001
2018
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Tetra Bio-PharmaLead Sponsor
7 Previous Clinical Trials
682 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer
2020. "Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04042545.
~17 spots leftby Apr 2025
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