Overview

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

Status:
Terminated
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm). At least 20% of the subjects enrolled will be age 65 years and older.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
POZEN
Treatments:
Arthrotec
Diclofenac
Esomeprazole
Misoprostol
Naproxen
Criteria
Inclusion Criteria:

1. Male or non-pregnant female subjects, 18 years and older with a history of
osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical
condition expected to require daily NSAID therapy for at least 6 months, with a
documented history of an ulcer related serious upper gastrointestinal event such as
bleeding, perforation or obstruction

2. Female subjects are eligible for participation in the study if they are of:

- Non-childbearing potential (i.e., physiologically incapable of becoming
pregnant);

- Childbearing potential, have a negative pregnancy test at screening, and at least
one of the following applies or is agreed to by the subject:

- Female sterilization or sterilization of male partner; or,

- Hormonal contraception by oral route, implant, injectable, vaginal ring; or,

- Any intrauterine device (IUD) with published data showing that the lowest
expected failure rate is less than 1% per year;

- Double barrier method (2 physical barriers or 1 physical barrier plus
spermicide); or

- Any other method with published data showing that the lowest expected
failure rate is less than 1% per year

3. Each subject must be able to understand and comply with study procedures required of a
subject and is able and willing to provide written informed consent prior to any study
procedures being performed

Exclusion Criteria:

1. History of hypersensitivity to esomeprazole or to another proton-pump inhibitor

2. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or a
history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps

3. Positive test result for H. pylori at screening

4. Participation in any study of an investigational treatment in the 4 weeks before
screening

5. Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal
disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that
would endanger a subject if they were to participate in the study

6. Gastrointestinal disorder or surgery leading to impaired drug absorption

7. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in
the investigator's opinion would endanger a subject if they were to participate in the
study

8. Schizophrenia or bipolar disorder

9. Use of any excluded concomitant medication (see Section 9.2)

10. A recent history (in the past 3 months) suggestive of alcohol or drug abuse or
dependence, including overuse/abuse of narcotics for management of pain

11. Serious blood coagulation disorder, including use of systemic anticoagulants

12. Screening endoscopy showing >10 erosions or any gastric or duodenal ulcer at least 3
mm in diameter with depth

13. Screening laboratory ALT or AST value > 2 times the upper limit of normal

14. Estimated creatinine clearance < 50 ml/min

15. Other than noted specifically, any screening laboratory value that is clinically
significant in the investigator's opinion and would endanger a subject if they were to
participate in the study

16. History of malignancy, treated or untreated, within the past 5 years, with the
exception of successfully treated basal cell or squamous cell carcinoma of the skin