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Completed Phase 2 Interventional

Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age

ClinicalTrials.gov ID: NCT02633969

Public ClinicalTrials.gov record NCT02633969. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 11:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase IIA, Open-label, Safety and Pharmacokinetic Study of Indomethacin Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.

Study identification

NCT ID
NCT02633969
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Iroko Pharmaceuticals, LLC
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2015 (Type not available)
Primary completion
Jan 2017 (Actual)
Completion
Jan 2017 (Actual)
Last update posted
Jan 26, 2018

2015 – 2017

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Not listed Sheffield Alabama 35660 —
Not listed Aurora Colorado 80045 —
Not listed Coral Gables Florida 33146 —
Not listed Durham North Carolina 27705 —
Not listed Orem Utah 84058 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02633969, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 26, 2018 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02633969 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →