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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00640705
Eligibility Criteria:
Inclusion Criteria:
* 18 to 75 years of age
* Has sustained a painful Grade 1 or 2 ankle sprain (Appendix H) no more than 48 hours prior to study entry
* Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)
Exclusion Criteria:
* Grade 3 ankle sprain or bilateral sprain (see Appendix H)
* Previous injury to the same ankle within 3 months prior to current injury
* Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B)
* Opioid use within 24 hours prior to study entry
* Topical treatment, other than ice packs, applied to the painful region since time of injury
* A history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder
* A history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout
* Clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
* A history of hypersensitivity to diclofenac or diclofenac-containing products
* A history of intolerance to acetaminophen (rescue medication in this trial)
* A history of skin sensitivity to adhesives (e.g. adhesive tape)
* Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00640705
Study Brief:
Protocol Section:
NCT00640705