Description:

ODM derived from http://clinicaltrials.gov/show/NCT00241514

Link:

http://clinicaltrials.gov/show/NCT00241514

Keywords:
Versions (1) ▾
  1. 12/11/13
Uploaded on:

December 11, 2013

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00241514 GERD

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age 18 Years and older
Signed informed consent.
Completed the SH-NEN-0001 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 and. Are expected to remain stable for the duration of the study. and. 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- 0001.
Exclusion Criteria
Discontinuation from study SH-NEN-0001
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.
Need for continuous concomitant therapy with: (Anticoagulants, Corticosteroids at doses higher than explained under inclusion criterion)