Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chapel Hill, North Carolina 27517


Purpose:

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.


Study summary:

To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control. Secondary: - To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk population - To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores (1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population - To compare gastrointestinal symptoms in subjects treated with PN 400 versus diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating Scale (GSRS) instrument - To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high risk population


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


NCT ID:

NCT00594854


Primary Contact:

Study Chair
Everardus Orlemans, PhD
POZEN


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27517
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.