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