Study of GD Irritation from OXP005 & reference (QCL117547;OXP005-002)

• Research type

  Research Study

• Full title

  An Open-Label, Randomised, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study with OXP005 Naproxen 250 mg Tablets and Naprosyn® 250 mg Tablets to Assess the Effects on Gastroduodenal Irritation in Normal, Healthy, Adult, Human Subjects

• IRAS ID

  174048

• Contact name

  Sheryl Caswell

• Contact email

  sheryl.caswell@pharmascience.co.uk

• Sponsor organisation

  Oxford Pharmascience Ltd

• Eudract number

  2015-000514-21

• Duration of Study in the UK

  0 years, 1 months, 7 days

• Research summary

  Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions.

  The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® - the reference product) by looking at the relative impact of both products on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.

• REC name

  Wales REC 2

• REC reference

  15/WA/0068

• Date of REC Opinion

  19 Mar 2015

• REC opinion

  Favourable Opinion