Trials / Completed
CompletedNCT02408978
Pilot Study of OXP005 to Assess Gastroduodenal Irritation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Oxford Pharmascience Ltd · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OXP005 | |
| DRUG | Naproxen |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2015-04-06
- Last updated
- 2015-06-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02408978. Inclusion in this directory is not an endorsement.