Clinical trial: Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs (NCT00241553)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent.

          -  Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as
             "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to
             be rated as Mild during the 7-day period".

          -  A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid
             arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily
             NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in
             any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose
             NSAIDs.

          -  Daily NSAID treatment dose and type:

          -  Must have been stable for at least 9 weeks prior to inclusion

          -  Are expected to remain stable for the duration of the study.

          -  Must be administered orally. If more than one type of NSAID treatment is used, at
             least one type must be administered orally.

          -  Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.

        Exclusion Criteria:

          -  Discontinuation from study SH-NEN-0003

          -  Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved
             by defecation.

          -  Pain, discomfort or burning in the upper abdomen not associated with the use of
             NSAIDs, including COX-2 selective NSAIDs.

          -  Pregnancy or lactation. Women of childbearing potential must maintain effective
             contraception during the study period as judged by the investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment