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Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain (REBORN)

Primary Purpose

Cancer, Breakthrough Cancer Pain

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PPP001

Morphine sulfate or Hydromorphone or Oxycodone

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent.
Adult male and female subjects at least 18 years of age.
Subject agrees to follow the protocol.
Confirmed diagnosis of cancer with life expectancy of more than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
If currently receiving chemotherapy and/or radiotherapy treatment, subjects must be on a stable regimen for at least one month (30 days ± 2 days) prior to screening.
Background cancer pain stable (pain <4/10 on numeric rating scale) and adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine.
Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD) for both background and breakthrough cancer pain.
The subject is currently taking chronic treatment with opiod analgesic but still has a clinical diagnosis of breakthrough cancer pain with <3 episodes per day but >3 episodes per week.
The subject is using only oral morphine sulfate for breakthrough opioid analgesia.
Normal cognitive status according to MiniCog.
The subject is able to perform deep inhalations with FEV1 more than 60%.
Ability to read and respond to questions in English.
A female subject 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 subject 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.

Sites / Locations

HRIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PPP001

Morphine sulfate or Hydromorphone or Oxycodone

Arm Description

Inhaled cannabinoids (PPP001)

Oral morphine sulfate or hydromorphone or oxycodone at the previous stabilized dosage

Outcomes

Primary Outcome Measures

Time weighted Sum of Pain Intensity Differences from 0 to 30 minutes (SPID30).

SPID30 score after PPP001 administration or immediate-release oral opioids (morphine sulfate or hydromorphone or oxycodone) administration. The SPID30 calculation is based on a 100 mm pain intensity VAS were 0 mm is the minimum and 100 mm the maximum with higher score representing a worse outcome.

Secondary Outcome Measures

SPID at 10, 15, and 60 minutes

SPID score after PPP001 administration or immediate-release oral opioids (morphine sulfate or hydromorphone or oxycodone) administration. The SPID calculation is based on a 100 mm pain intensity VAS were 0 mm is the minimum and 100 mm the maximum with higher score representing a worse outcome.

Pain intensity difference (PID)

PID score after PPP001 administration or immediate-release oral opioids (morphine sulfate or hydromorphone or oxycodone) administration. The PID calculation is based on a 100 mm pain intensity VAS were 0 mm is the minimum and 100 mm the maximum with higher score representing a worse outcome.

Pain relief at 5, 10, 15, 30 and 60 minutes

Subjective pain relief evaluated with a self-administered scale. The pain relief is measured with a five-point scale (0 = none to 4 = complete relief) with a higher score representing a better outcome.

Full Information

NCT ID

NCT03564548

First Posted

May 22, 2018

Last Updated

July 21, 2021

Sponsor

Tetra Bio-Pharma

Collaborators

Cognitive Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03564548

Brief Title

Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain

Acronym

REBORN

Official Title

Inhaled PPP001 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: a Randomized, Open Label, Crossover, Comparison Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 26, 2021 (Actual)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tetra Bio-Pharma

Collaborators

Cognitive Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Breakthrough cancer pain (BTcP) is a rapid onset, high intensity and short duration pain episode, which takes place within stable background pain control. It significantly affects the quality of life of patients with cancer and their ability to function normally. Rapid onset opioids and immediate-release oral opioids (e.g. morphine sulfate, hydromorphone, and oxycodone) are the standard treatment for BTcP. Because of the limited availability, high cost, complicated titration and the high risks of overdosing with rapid-onset opioids, most often the preferred choice of treatment is immediate-release oral opioids. However, this approach might not always offer optimal speed for onset of action and duration to match the rapid nature of an episode of BTcP. In order to seek a potential alternative to immediate-release oral opioids, we are proposing to test the onset of action of PPP001 to rapidly alleviate breakthrough pain in patients with cancer. We will also examine the safety and the efficacy on pain intensity of PPP001 within this population.

Detailed Description

The study is a randomized, open-label crossover comparison study: This will be a 10-week open-label randomized study to evaluate the effect of inhaled PPP001 as compared to morphine sulfate or hydromorphone or oxycodone to improve for the treatment of BTcP. After proper screening and verified inclusion/exclusion criteria, 20 consecutive subjects will be recruited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Breakthrough Cancer Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PPP001

Arm Type

Experimental

Arm Description

Inhaled cannabinoids (PPP001)

Arm Title

Morphine sulfate or Hydromorphone or Oxycodone

Arm Type

Active Comparator

Arm Description

Oral morphine sulfate or hydromorphone or oxycodone at the previous stabilized dosage

Intervention Type

Drug

Intervention Name(s)

PPP001

Intervention Description

Group assigned to PPP001

Intervention Type

Drug

Intervention Name(s)

Morphine sulfate or Hydromorphone or Oxycodone

Intervention Description

Group assigned to morphine sulfate or hydromorphone or oxycodone

Primary Outcome Measure Information:

Title

Time weighted Sum of Pain Intensity Differences from 0 to 30 minutes (SPID30).

Description

Time Frame

change between 0 min (before starting treatment) and 30 minutes after dosing

Secondary Outcome Measure Information:

Title

SPID at 10, 15, and 60 minutes

Description

Time Frame

10, 15, and 60 minutes after dosing

Title

Pain intensity difference (PID)

Description

Time Frame

5, 10, 15, 30 and 60 minutes after dosing

Title

Pain relief at 5, 10, 15, 30 and 60 minutes

Description

Time Frame

5, 10, 15, 30 and 60 minutes after dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent. Adult male and female subjects at least 18 years of age. Subject agrees to follow the protocol. Confirmed diagnosis of cancer with life expectancy of more than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. If currently receiving chemotherapy and/or radiotherapy treatment, subjects must be on a stable regimen for at least one month (30 days ± 2 days) prior to screening. Background cancer pain stable (pain <4/10 on numeric rating scale) and adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine. Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD) for both background and breakthrough cancer pain. The subject is currently taking chronic treatment with opiod analgesic but still has a clinical diagnosis of breakthrough cancer pain with <3 episodes per day but >3 episodes per week. The subject is using only oral morphine sulfate for breakthrough opioid analgesia. Normal cognitive status according to MiniCog. The subject is able to perform deep inhalations with FEV1 more than 60%. Ability to read and respond to questions in English. A female subject 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 subject 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tetra Bio Pharma

Phone

438 899 7575

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell Hassman

Organizational Affiliation

Hassman Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

HRI

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mitchell Hassman, MBA

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain

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