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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT02633969
Eligibility Criteria:
Inclusion Criteria:
* Body weight ≥20 kilograms
* Mild to moderate acute pain requiring treatment with analgesic medication
* Willing to have blood samples taken for PK sampling using an indwelling catheter
* Must be able to swallow capsules and can tolerate oral medication
* For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control
Exclusion Criteria:
* Severe acute pain
* Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug
* Emergency surgery
* History of allergic reaction, hypersensitivity, or clinically significant intolerance to indomethacin, aspirin, codeine, acetaminophen, or any NSAID
* History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
* Current use of any medication that may cause a clinically significant drug interaction when co-administered with indomethacin
* Current use of any medication that might affect the pharmacokinetics of indomethacin
* History of bleeding disorders
* Developmental delay or behavioral problems that would make it difficult to assess pain
* Impaired liver function
* Clinically significant renal or cardiovascular disease
* Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
* Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study
* Previous participation in this clinical study or currently taking indomethacin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT02633969
Study Brief:
Protocol Section:
NCT02633969