Pilot Study of OXP005 to Assess Gastroduodenal Irritation
- Registration Number
- NCT02408978
- Lead Sponsor
- Oxford Pharmascience Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OXP005 OXP005 1g naproxen naproxen Naproxen 1g naproxen
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Clinical Ltd
🇬🇧Nottingham, United Kingdom