Refractory Chronic Cough

• Research type

  Research Study

• Full title

  A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-selection study of S-600918 in patients with refractory chronic cough

• IRAS ID

  273508

• Contact name

  Lorcan McGarvey

• Contact email

  l.mcgarvey@qub.ac.uk

• Sponsor organisation

  Shionogi B.V

• Eudract number

  2019-002283-27

• Clinicaltrials.gov Identifier

  NCT04110054

• Duration of Study in the UK

  1 years, 2 months, 5 days

• Research summary

  This is a clinical research study of a potential new treatment called S-600918 in participants refractory chronic cough.
  Refractory chronic cough is defined as chronic cough that continues after treatment for the disease(s) causing the cough or as unexplained chronic cough for which the disease has not been determined Adenosine triphosphate (ATP) functions as a transcellular signalling substance and induces the cough reflex when inhaled in humans. Among the receptors the P2X receptor is a subtype of an ion channel gated by ATP as a ligand. Seven subtypes of this receptor have been identified and it has been suggested that the P2X3 receptor has significant involvement in the cough reflex.S-600918 is a P2X3 receptor antagonist developed by Shionogi B.V.

  The reason for this study is to determine the optimal dose of S-600918 in participants with refractory chronic cough.

  This study will include a total of 372 participants, with approximately 77 participants from 15 sites expected in the UK.
  Study participation will last between approximately 8 and 10 weeks. The study is divided into 3 separate
  periods:
  • Screening Period: Visit 1 (28 to 18 days before receiving study drug), Visit 2 (1 day before receiving study drug)
  • Treatment Period: Visits 3 (first day you receive study drug), Visit 4 (1 week after Visit 3), Visit 5 (2 weeks after Visit 4), Visit 6 (approximately 1 week after Visit 5)
  • Follow-up Period:
  Early Discontinuation Visit: (if study drug is stopped before the end of the study)
  End of study - Visit 7 (Day 42, 2 weeks after last dose of study drug)

  Study participants will be placed randomly into one of three treatment groups in a 1:1:1 ratio to the study treatment:
  • S-600918 50 mg
  • S-600918 150 mg
  • S-600918 300 mg
  • Placebo Group

  The study involves procedures including: physical examination, vital signs, blood tests, electrocardiogram (ECG) and chest x-ray

  This is a double-blinded study sponsored by Shionogi B.V.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  20/NW/0006

• Date of REC Opinion

  18 Mar 2020

• REC opinion

  Further Information Favourable Opinion