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

NCT03564548 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: PPP001-Ph2-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Breakthrough Cancer Pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• SPID at 10, 15, and 60 minutes

  10, 15, and 60 minutes after dosing

• Pain intensity difference (PID)

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

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

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

Study Arms (2)

PPP001

EXPERIMENTAL

Inhaled cannabinoids (PPP001)

Drug: PPP001

Morphine sulfate or Hydromorphone or Oxycodone

ACTIVE COMPARATOR

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

Drug: Morphine sulfate or Hydromorphone or Oxycodone

Interventions

PPP001 DRUG

Group assigned to PPP001

PPP001

Morphine sulfate or Hydromorphone or Oxycodone DRUG

Group assigned to morphine sulfate or hydromorphone or oxycodone

Morphine sulfate or Hydromorphone or Oxycodone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Tetra Bio-Pharma: lead
• Cognitive Research Corporation: collaborator

Study Sites (1)

HRI

Berlin, New Jersey, 08009, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Morphine; Hydromorphone; Oxycodone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• Mitchell Hassman

  Hassman Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tetra Bio Pharma

CONTACT

438 899 7575

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 21, 2018
• Study Start: May 26, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

US (1)