10 June 2006
VERSION: 1 2 3 4 5 6 7 8 9

AT RISK NSAID-associated Ulcers 302 Trial
A 6-Month, Phase 3, randomized, double-blind, controlled, multi-center study to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers

Study Drug: PN 200 (Omeprazole 20 mgm and EC Naproxen 500 mgm) taken Bid
Protocol: PN200-302
Sponsor: POZEN Inc.
Study Phase 3
CRO: SCIREX
Site #:
CRA:
Central Lab: ACM Medical Labs
IRB: WIRB
Subjects 400/ 50 Sites -> 8 Subjects per Site R 1:1 to: PN200 vs. Naproxen alone for 6 months
Breakthrough Meds: Tylenol + Mylanta

IC
Age 18-49 AND have a h/o documented, uncomplicated gastric or duodenal ulcer (a mucosal break of at least 3 mm in diameter with depth, without any concurrent bleeding, clot or perforation) within the past 5 years
Age greater than/equal to 50 (these subjects do not require a h/o a documented, uncomplicated gastric or duodenal ulcer within the past 5 years)
All subjects must require daily NSAIDs for the next 6 months or more

EC

Positive test result for HP at screening
Baseline Endoscopy GU or DU greater than/equal to 3 mm in diameter with depth
LFT’s > 2 x's ULN
Cancer within 5 years
Coumadin or Aggrenox
ASA PLUS Plavix (either alone OK)
eGFR < 30 ml/min
Cytotec
Intraarticular Steroids or ICS (PO Steroids OK)
Fosamax

10 June 2006
VERSION: 1 2 3 4 5 6 7 8 9

AT RISK NSAID-associated Ulcers 302 Trial

V1 W 1 Lab, ICF, Screening, EKG, Stool for HP, Washout PPI x 7-14 days prior to V2
(Schedule Endo Now or if on PPI, after off PPI x 1 week)
V2 W 2 Screening; May combine V2 + V3; Review Endo Results
V3 D 1 Baseline; (As soon as Endo results available may do V3, but, within 7 days of Endo) R
(Schedule next Endo 3 Days before V4)
V4 D 30 +/- 3 Days from Baseline V, Endo, Lab
(Treatment Period) (Schedule next Endo 3 Days before V5)
V5 D 90 +/- 3 Days from Baseline V, Endo, Lab
(Schedule next Endo 9 Days before V6)
V6 D 180 +/- 9 Days from Baseline V or Early Term, Endo