Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT00597818
Eligibility Criteria:
Inclusion Criteria:
* Patient is more than 40 and less than 70 years of age.
* Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
* No current gastrointestinal H. pylori infection.
Exclusion Criteria:
* Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated condition(s) to NSAID therapy.
* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
* Medical history includes prior or active GI complications and/or disorders, including but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD).
* Active symptomatic peptic ulcer disease or GI bleeding.
* Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00597818
Study Brief:
Protocol Section:
NCT00597818