NCT02408978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

March 31, 2015

Last Update Submit

June 17, 2015

Conditions

Gastroduodenal Erosions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

OXP005

EXPERIMENTAL

1g naproxen

Drug: OXP005

naproxen

ACTIVE COMPARATOR

1g naproxen

Drug: Naproxen

Interventions

OXP005DRUG
OXP005
NaproxenDRUG
naproxen

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical Ltd

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Stuart Mair, MBChB, DRCOG

    Quotient Clinical Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 6, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

GB(1)