Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Oxford Pharmascience

Status and phase

Completed

Phase 1

Conditions

Gastroduodenal Erosions

Treatments

Drug: OXP005

Drug: Naproxen

Study type

Interventional

Funder types

Industry

Identifiers

NCT02408978

OXP005-002

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female subject
Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum)
H. pylori negative

Exclusion criteria

Clinically significant abnormal laboratory parameters
Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, centralcnervous, immunological, dermatological, GI or any other body system