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Cancer

InhaleRx Ltd. Registers Clinical Trial to Evaluate Efficacy and Safety of IRX211a for Treatment of Breakthrough Cancer Pain

Strategic Insights

— 1 min read

InhaleRx Ltd. has registered a Phase 2 clinical trial with the Australian New Zealand Clinical Trials Registry (ANZCTR) to investigate the efficacy and safety of IRX211a for the treatment of breakthrough cancer pain in opioid-tolerant patients. The study aims to determine whether IRX211a can provide fast and effective pain relief for sudden pain episodes. The trial will evaluate 100 participants aged 18 years or above with a current diagnosis of cancer and experiencing breakthrough cancer pain.

Key Takeaways:

  • The clinical trial is a Phase 2 double-blind, placebo-controlled, multicenter cross-over study with a titration period.
  • The study will evaluate the efficacy and safety of IRX211a for breakthrough cancer pain in opioid-tolerant patients.
  • The trial will involve 100 participants aged 18 years or above with a current diagnosis of cancer and experiencing breakthrough cancer pain.
  • The study has two parts: a titration phase to determine the effective individualized dose, and a placebo-controlled RCT phase to evaluate pain relief.
  • The titration phase will occur over a maximum of 3 weeks, with participants receiving increasing increments of IRX211a until they reach their effective individualized dose.
  • In Part B, participants will receive 10 numbered pMDI inhalers in a pre-randomized sequence, containing either active IRX211a or matching placebo, to treat up to 10 BTcP episodes.
  • The main goal of the study is to find out whether IRX211a can provide fast and effective pain relief for BTcP.
  • The study hypothesis is that IRX211a will provide better and faster pain relief than placebo when used as an additional treatment for sudden pain episodes.

Statistics:

  • 100 participants will be screened for the study.
  • The study will involve two phases: a 3-week titration phase and a 4-week placebo-controlled RCT phase.
  • Participants will receive increasing increments of IRX211a up to a maximum dose of 3.5mg.
  • 10 BTcP episodes will be treated using the individualized dose in Part B.

Sources:

  • Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12625000898459.

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