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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT00236535
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute ankle sprain with a partial ligament tear within 48 hours of study entry
* At least moderate pain from the ankle sprain at baseline and before first dose of study medication
* In generally good health
* If female of childbearing potential, using acceptable method of birth control
Exclusion Criteria:
* Use of ibuprofen within 6 hours or topical pain relievers within 12 hours of study entry
* Use of tramadol HCl, tramadol HCl/acetaminophen, or hydrocodone bitartrate/acetaminophen within 30 days of study entry
* Use of epilepsy or antidepressant medications 3 weeks before the study entry
* Chronic use of pain medications or muscle relaxants for any reason during the study
* No use of steroid medications (oral or inhaled) on a chronic basis
* Required hospitalization to treat the ankle sprain
* Head trauma
* Pain greater than the pain caused by the ankle sprain
* Complete ligament tear
* Bone fractures on x-ray
* Required physical therapy, other than for crutch training
* History of kidney damage
* Pregnant or breast-feeding patients
* Condition that might affect the way the body absorbs or processes the study medication
* Major psychiatric disorder, history of attempted suicides/suicidal tendencies
* History of substance abuse or chronic alcohol abuse in the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00236535
Study Brief:
Protocol Section:
NCT00236535