Knee flare up study

• Research type

  Research Study

• Full title

  A Three Arm Double blind, Randomised Multicentre Study to Investigate the Non-Inferiority of a Soft Gel Capsule of Ibuprofen Lipid Formulation (total daily dose 1200 mg) versus a Standard Soft Gel Ibuprofen Capsule (total daily dose 1200 mg and 2400 mg) in the Treatment of Patients with Episodic Knee Arthralgia/Flaring Knee Pain.

• IRAS ID

  180323

• Contact name

  Viv Edwards

• Contact email

  viv.edwards@infirst.co.uk

• Sponsor organisation

  Infirst+ HEALTHCARE Ltd

• Eudract number

  2014-004254-33

• Duration of Study in the UK

  0 years, 7 months, 2 days

• Research summary

  This study is being carried out to examine the safety and effectiveness of a new type of capsule of ibuprofen for the relief of frequent knee pain associated with osteoarthritis. The study will compare the new capsule with a high and low dose of standard ibuprofen capsules. The study will involve a 5-day treatment course. The new capsule type is anticipated to be as effective as the standard capsules and to reduce the side effects on the digestive system which some people experience with the standard capsules.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  15/EM/0230

• Date of REC Opinion

  22 Jun 2015

• REC opinion

  Further Information Favourable Opinion