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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OXP005 | Experimental | 1g naproxen |
|
| naproxen | Active Comparator | 1g naproxen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OXP005 | Drug |
| ||
| Naproxen |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair, MBChB, DRCOG | Quotient Clinical Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |