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

HIGH RISK NSAID-associated Ulcers 303 Trial
A 6-Month, Multi-center Study to Evaluate the Gastroduodenal Protective Effects of PN 200 in Subjects Who Are at High Risk for Developing NSAID-associated Ulcers

Sponsor: POZEN Inc.
Study Drug: PN 200 (Omeprazole 20 mgm and EC Naproxen 500 mgm) taken Bid
Protocol: PN200-302
Phase 3
CRO: SCIREX
Site #
: CRA:
Central Lab: ACM Medical Labs
IRB: WIRB
Subjects 200/ 50 Sites -> 4 Subjects per Site R 1:1 to: PN200 vs. Naproxen Plus Prevacid 15 mgm for 6 months
Breakthrough Meds: Tylenol + Mylanta

IC
Age equal/greater than 18 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
Require daily NSAID’s for the next 6 months
EC
Positive test result for HP at screening
Baseline Endoscopy GU or DU equal/greater than 3 mm in diameter with depth
LFT’s > 2 times ULN
Cancer within 5 years
Coumadin or Aggrenox
Plavix Plus ASA (either alone OK)
Cytotec
Intraarticular steroids or ICS (Stable PO Steroids OK)
Fosamax

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

HIGH RISK NSAID-associated Ulcers 303 Trial

V1 D-7 to 0 Lab; ICF; Screening, EKG; Stool for HP Washout PPI x 7-14 days prior to V2
(Schedule Endo 3 days before V2)
V2 D 1 Baseline/Randomization, Endo, R
(Schedule Endo 3 days before V3)
V3 D 30 +/- 3 Days from Baseline V; Endo; Lab
(Schedule Endo 6 days before V4)
V4 D 90 +/- 6 Days from Baseline V; Endo; Lab
(Schedule Endo 9 days before V5)
V5 D 180 +/- 9 Days from Baseline V, Endo; Lab