Gastroduodenal Erosions
Conditions
Brief 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.
Interventions
DRUGOXP005
DRUGNaproxen
Sponsors
Oxford Pharmascience Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of GD irritation in the stomach and duodenum as measured by the Lanza score | Day 8 |
| Total number of GD erosions overall | Day 8 |
Countries
United Kingdom
Outcome results
None listed