Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Gastroduodenal Erosions Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408978
• Other study ID #: OXP005-002
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2015
• Last updated: June 17, 2015
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Oxford Pharmascience Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastroduodenal Erosions

Intervention

Drug:
• OXP005

• Naproxen

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Pharmascience Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of GD irritation in the stomach and duodenum as measured by the Lanza score		Day 8	Yes
Primary	Total number of GD erosions overall		Day 8	Yes