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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01066520
Eligibility Criteria:
Inclusion criteria:
* Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle joint both male and female
* Moderate (30-60 mm) to severe (\>60 mm) pain according to the patient's assessment of ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal training / sports activities
* 18 - 40 years of age
* injury occurred within 24 hours of the first dose of study medication
* Willing and able to give written informed consent
* Available for the duration of the study
Exclusion Criteria:
* Similar injury affecting the same joint within the past 6 months
* bilateral ankle injury
* bed rest, hospitalization, surgery use of a non-removable rigid cast
* Clinically important abnormality for screening laboratory tests
* Debilitating acute or chronic illness
* Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol
* History of sensitivity to any component of the study drugs
* Unwilling or unable to comply with all the requirements of the protocol
* Participation in other studies within 4 weeks prior to study entry and or during the study participation
* Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01066520
Study Brief:
Protocol Section:
NCT01066520