An AllTrials project

NCT02633969: An overdue trial by Iroko Pharmaceuticals, LLC

This trial is overdue. It was due to report 6 years, 9 months ago.

Think we've made a mistake? Before contacting us, review the criteria in our paper. In particular, bear in mind the following:

  • We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
  • Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
  • Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.

Full data

Full entry on ClinicalTrials.gov NCT02633969
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
Results Status Overdue
ACT or pACT? This is what FDAAA officially calls a "probable Applicable Clinical Trial"
Start date Dec. 31, 2015
Completion date Jan. 31, 2017
Required reporting date Jan. 31, 2018, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov Feb. 9, 2024
Days late 2200