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Pilot Study of OXP005 to Assess Gastroduodenal Irritation

NCT02408978 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-06-18

No results posted yet for this study

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.

Conditions

  • Gastroduodenal Erosions

Interventions

DRUG

OXP005

DRUG

Naproxen

Sponsors & Collaborators

  • Oxford Pharmascience Ltd

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MBChB, DRCOG · Quotient Clinical Ltd

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408978 on ClinicalTrials.gov