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

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ClinicalTrials.gov Identifier: NCT03564548
Recruitment Status : Suspended (postponed later)
First Posted : June 21, 2018
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Cognitive Research Corporation
Information provided by (Responsible Party):
Tetra Bio-Pharma

Study Description
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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 (morphine sulfate) 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 PPP011 to rapidly alleviate breakthrough pain in patients with cancer. We will also examine the safety and the efficacy on pain intensity of PPP011 within this population, for four weeks or longer administration.

Condition or disease Intervention/treatment Phase
Cancer Breakthrough Cancer Pain Drug: PPP011 Drug: Morphine sulfate Phase 2

Detailed Description:

This is a pilot study that will be conducted at the Hassman Research Institute. It consists of two sub-studies; Sub-study A will be completed and analyzed prior to starting Sub-study B:

  1. Sub-study A is an open-label crossover comparison study: This will be a 12-week open-label randomized study to evaluate the effect of inhaled PPP011 as compared to morphine sulfate to improve fast onset of pain relief of BTcP. After proper screening and verified inclusion/exclusion criteria, 20 consecutive subjects will be recruited to participate in Sub-study A.
  2. Sub-study B is a randomized double-blind placebo-controlled trial: This will be a 7-week study to evaluate the effect of inhaled PPP011 or morphine sulfate to improve onset of pain relief when compared to placebo in subjects with BTcP. After proper screening and verified inclusion/exclusion criteria, 40 consecutive subjects will be recruited prospectively to participate in this trial. The same inclusion/exclusion criteria of the open-label study will be applied. The subjects recruited for this study will be different from those recruited for the open-label study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The first part of the study will be in a crossover model and the second part in a parallel model
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Inhaled PPP011 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: an Open Label, Crossover, Comparison Study Followed by a Randomized, Double-blind, Placebo-controlled Pilot Trial
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CAUMZ PPP011
Inhaled synthetic cannabinoids (PPP011)
 Drug: PPP011
Group assigned to PPP001 during the open-label
Active Comparator: Morphine sulfate
Oral morphine sulfate at the previous stabilized dosage
 Drug: Morphine sulfate
Group assigned to morphine sulfate during the open-label


Outcome Measures
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Primary Outcome Measures :
  1. Pain unpleasantness difference (PUD) at BTcP onset [ Time Frame: change between 0 min (before starting treatment) and 10 minutes after BTcP onset based on the VAS score ]
    PU score after PPP011 administration on request and/or morphine sulfate administration on request. PUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment.

  2. Pain unpleasantness difference (PUD) at BTcP onset [ Time Frame: change between 0 min (before starting treatment) and 30 minutes after BTcP onset based on the VAS score ]
    PU score after PPP011 administration on request and/or morphine sulfate administration on request. PUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment.

  3. Pain unpleasantness difference (PUD) at BTcP onset [ Time Frame: change between 0 min (before starting treatment) and 60 minutes after BTcP onset based on the VAS score ]
    PU score after PPP011 administration on request and/or morphine sulfate administration on request. PUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment.

  4. The sum of pain unpleasantness differences (SPUD) that equals to the area under the curve for PUD/time interval in minutes [ Time Frame: This will be measured for the 0-30 minutes interval (SPUD0-30) and the 0-60 minutes interval (SPUD0-60). SPUD is assessed after BTcP onset during the 2 weeks of PPP011 chronic treatment. ]

Secondary Outcome Measures :
  1. measurement of Pain Unpleasantness (PU) relief [ Time Frame: VAS will be completed at 0 min (immediately after BTcP onset, before treatment administration), and 10 ±2 min, 30 ±2 min and 60 ±2 minutes after PPP011 or morphine sulfate administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent.
  2. Adult male and female subjects at least 18 years of age.
  3. Subject agrees to follow the protocol.
  4. Confirmed diagnosis of cancer with life expectancy of more than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  5. 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.
  6. Background cancer pain stable (pain <4/10 on numeric rating scale) and adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine.
  7. Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD) for both background and breakthrough cancer pain.
  8. 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.
  9. The subject is using only oral morphine sulfate for breakthrough opioid analgesia.
  10. Normal cognitive status according to MiniCog.
  11. The subject is able to perform deep inhalations with FEV1 more than 60%.
  12. Ability to read and respond to questions in English.

  13. 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

  14. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564548


Locations
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United States, New Jersey
HRI
Berlin, New Jersey, United States, 08009
Sponsors and Collaborators
Tetra Bio-Pharma
Cognitive Research Corporation
Investigators
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Principal Investigator: Mitchell Hassman Hassman Research Institute
More Information
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Responsible Party: Tetra Bio-Pharma
ClinicalTrials.gov Identifier: NCT03564548    
Other Study ID Numbers: PPP011-Ph2-02
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents