Inhaled PPP001 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: a Randomized, Open Label, Crossover, Comparison Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time weighted Sum of Pain Intensity Differences from 0 to 30 minutes (SPID30).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- 未提供
研究组 & 干预措施
PPP001
Inhaled cannabinoids (PPP001)
干预措施: PPP001 (Drug)
Morphine sulfate or Hydromorphone or Oxycodone
Oral morphine sulfate or hydromorphone or oxycodone at the previous stabilized dosage
干预措施: Morphine sulfate or Hydromorphone or Oxycodone (Drug)
结局指标
主要结局
Time weighted Sum of Pain Intensity Differences from 0 to 30 minutes (SPID30).
时间窗: change between 0 min (before starting treatment) and 30 minutes after dosing
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.
次要结局
- Pain relief at 5, 10, 15, 30 and 60 minutes(5, 10, 15, 30 and 60 minutes after dosing)
- 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)