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Opioid

PPP001 for Cancer (REBORN Trial)

Phase 2
Waitlist Available
Led By Mitchell Hassman
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 between 0 min (before starting treatment) and 30 minutes after dosing
Awards & highlights

REBORN Trial Summary

This study is evaluating whether a new drug may help treat breakthrough cancer pain.

Eligible Conditions
  • Cancer
  • Cancer Related Pain

REBORN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between 0 min (before starting treatment) and 30 minutes after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between 0 min (before starting treatment) and 30 minutes after dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time weighted Sum of Pain Intensity Differences from 0 to 30 minutes (SPID30).
Secondary outcome measures
Pain intensity difference (PID)
Pain relief at 5, 10, 15, 30 and 60 minutes
SPID at 10, 15, and 60 minutes

REBORN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PPP001Experimental Treatment1 Intervention
Inhaled cannabinoids (PPP001)
Group II: Morphine sulfate or Hydromorphone or OxycodoneActive Control1 Intervention
Oral morphine sulfate or hydromorphone or oxycodone at the previous stabilized dosage
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
740 Total Patients Enrolled
Cognitive Research CorporationIndustry Sponsor
23 Previous Clinical Trials
2,310 Total Patients Enrolled
Mitchell HassmanPrincipal InvestigatorHassman Research Institute

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
Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain
2021. "Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03564548.
All > Opiate Addiction
~5 spots leftby Apr 2025
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