Description:

ODM derived from http://clinicaltrials.gov/show/NCT00241540

Link:

http://clinicaltrials.gov/show/NCT00241540

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 NCT00241540 GERD

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
18 years of age, or older
Capable of completing the diary card
Ability to complete the HRQL questionnaires
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 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 aspirin (>325 mg/day).
Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and. Are expected to remain stable for the duration of the study. and. Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).
Exclusion Criteria
Current, or history of, gastric or duodenal ulcer
Current, or history of, esophageal, gastric or duodenal surgery.
History of GERD, not associated with NSAID use.
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, as judged by the investigator.
Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus