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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00450658
Eligibility Criteria:
Inclusion Criteria:
* Expected to require daily administration of a nonsteroidal anti-inflammatory drug (NSAID) for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
* Did not use a NSAID within the 30 days prior to study entry
Exclusion Criteria:
* History of erosive esophagitis
* History of any of the following serious gastrointestinal complications:
* perforation of ulcers,
* gastric outlet obstruction due to ulcers,
* gastrointestinal bleeding.
* Active cardiac, renal, and/or hepatic disease
* Current Helicobacter pylori (H. pylori) infection
* Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
* Uncontrolled diabetes
* Uncontrolled hypertension
* Positive pregnancy test at screening
* Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* Currently participating, or participation within 30 days prior to study entry, in an investigational drug study
Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00450658
Study Brief:
Protocol Section:
NCT00450658