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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT02113566
Eligibility Criteria:
Inclusion Criteria:
* are male or female, 18-55 years of age
* are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
* have a history of experiencing muscle soreness after moderately strenuous exercise
* are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
* are able to read, comprehend, and sign the informed consent form
* develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale
Exclusion Criteria:
* regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
* works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
* allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
* the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
* any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
* current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
* currently on chronic NSAID therapy for any reason
* current or recent history of drug or alcohol abuse
* has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
* has donated blood within the past 30 days
* is unable to swallow whole or large tablets or capsules
* is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
* participation in an investigational study within the past 30 days of screening
* prior participation in this trial
* site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02113566
Study Brief:
Protocol Section:
NCT02113566