A Phase 2 interventional study of PPP001 and Morphine sulfate or Hydromorphone or Oxycodone in Cancer and Breakthrough Cancer Pain, sponsored by Tetra Bio-Pharma. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Tetra Bio-Pharma · Phase 2, Interventional, and Treatment
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.
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.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Tetra Bio-Pharma is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Inclusion Criteria:
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
Inhaled cannabinoids (PPP001)
Drug: PPP001
Oral morphine sulfate or hydromorphone or oxycodone at the previous stabilized dosage
Drug: Morphine sulfate or Hydromorphone or Oxycodone
Group assigned to PPP001
Group assigned to morphine sulfate or hydromorphone or oxycodone
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.
Time frame: change between 0 min (before starting treatment) and 30 minutes after dosing
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.
Time frame: 10, 15, and 60 minutes after dosing
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.
Time frame: 5, 10, 15, 30 and 60 minutes after dosing
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.
Time frame: 5, 10, 15, 30 and 60 minutes after dosing
Plan to share: Undecided
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Tetra Bio-Pharma