Skip to main content
OpenTrials
Completed

NCT Number: NCT02408978

Pilot Study of OXP005 to Assess Gastroduodenal Irritation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroduodenal Erosions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OXP005

Drug

Naproxen

Drug

Primary outcomes

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

    Time frame: Day 8

  2. Total number of GD erosions overall

    Time frame: Day 8

Sponsors and collaborators

Lead sponsor

Oxford Pharmascience Ltd

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2015
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.