Study on different doses of cold treatment on nasal congestion

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group Efficacy Study of Different Doses of Phenylephrine Hydrochloride Combined with Paracetamol and/or Ibuprofen in Participants with Nasal Congestion Associated with Common Cold.

• IRAS ID

  182891

• Contact name

  Moutaz S M Jawad

• Contact email

  jawadms@cardiff.ac.uk

• Sponsor organisation

  AFT Pharmaceuticals Ltd

• Eudract number

  2015-002385-23

• Duration of Study in the UK

  0 years, 7 months, 9 days

• Research summary

  Nasal congestion is the most frequent symptom in patients experiencing common cold and occurring in 90% of cases and is the most troubling symptom from a patients perspective. The purpose of the study is to determine whether the effectiveness of the nasal decongestant Phenylephrine when combined with Paracetamol and Ibuprofen is similar with that of Phenylephrine administered alone.

  A maximum of 275 volunteers are expected to participate in this study, which is being conducted at the Common Cold Centre & Healthcare Clinical Trials.

• REC name

  Wales REC 2

• REC reference

  15/WA/0244

• Date of REC Opinion

  31 Jul 2015

• REC opinion

  Further Information Favourable Opinion