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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT01586494
Eligibility Criteria:
Inclusion Criteria:
* Confirmed need for control of pain due to injury or nonmalignant disease that does not influence fluid shifts and general drug disposition
* Weighs at least 20 kg
* Female participants must be premenarchal and in the opinion of the investigator not sexually active
* Able to swallow the intact tablet with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
* Signed informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study
* Informed consent signed by the parent(s) or the legal guardian(s) of the participant
Exclusion Criteria:
* History of or current clinically significant medical illness or condition including (but not limited to) cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
11 Years
Study:
NCT01586494
Study Brief:
Protocol Section:
NCT01586494