Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Oxford Pharmascience Ltd

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Conditions

Gastroduodenal Erosions

Interventions

OXP005DRUG

NaproxenDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Clinical Ltd

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Severity of GD irritation in the stomach and duodenum as measured by the Lanza score

Time frame: Day 8

Total number of GD erosions overall

Time frame: Day 8

Data from ClinicalTrials.gov

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