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:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00351104
Eligibility Criteria:
Inclusion Criteria:
* Males or females 18 years of age or older
* Diagnosis of Grade I or Grade II ankle sprain or strain
* Meet pain entry criteria
* Willing to discontinue use of any pain medication not provided as part of the study
Exclusion Criteria:
* Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
* Have received corticosteroids in the 30 days preceding screening
* Have a history or physical examination finding that is incompatible with safe participation in the study
* Have a history or physical examination finding that is incompatible with study product use
* Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
* Are taking medications that may significantly affect renal function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00351104
Study Brief:
Protocol Section:
NCT00351104