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NCT02633969 · ClinicalTrials.gov registry record · Phase 2
Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
A Phase 2 study, sponsored by Iroko Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02633969: Completed Phase 2 study, sponsored by Iroko Pharmaceuticals.
NCT02633969 is a Phase 2 study that has completed, run by Iroko Pharmaceuticals. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633969, a Phase 2 study, has completed, sponsored by Iroko Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The estimated typical value for clearance (tvCL) following a single indomethacin dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.
Interventions
- DRUG Indomethacin Capsules low dose
- DRUG Indomethacin Capsules high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT02633969 record still lists
NCT02633969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Indomethacin Capsules low dose is the first listed.
NCT02633969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02633969 about?
NCT02633969 is a clinical study titled "Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age". 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.
What is the current status of trial NCT02633969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-12. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02633969?
The interventions under investigation include: Indomethacin Capsules low dose (DRUG), Indomethacin Capsules high dose (DRUG).
Who is sponsoring clinical trial NCT02633969?
This trial is sponsored by Iroko Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02633969's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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