Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Gastroduodenal Erosions Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastroduodenal Erosions

• NCT number: NCT02408978
• Study type: Interventional
• Source: Oxford Pharmascience Ltd
• Status: Completed
• Phase: Phase 1
• Start date: May 2015
• Completion date: June 2015