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NCT01363076 · ClinicalTrials.gov registry record · Phase 1
The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
A Phase 1 study, sponsored by Egalet.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01363076: Completed Phase 1 study, sponsored by Egalet.
NCT01363076 is a Phase 1 study that has completed, run by Egalet. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363076, a Phase 1 study, has completed, sponsored by Egalet.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit. Following surgery, subjects received IN ketorolac 15 mg (weight \< 50 kg) or 30 mg (weight \> or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.
Primary Outcome
Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.
Interventions
- DRUG Ketorolac Tromethamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT01363076 record still lists
NCT01363076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketorolac Tromethamine is the first listed.
NCT01363076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363076 about?
NCT01363076 is a clinical study titled "The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years". This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit. Following surgery, subjects received IN ketorolac 1...
What is the current status of trial NCT01363076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-06. Estimated completion is 2008-05.
What interventions are being tested in trial NCT01363076?
The interventions under investigation include: Ketorolac Tromethamine (DRUG).
Who is sponsoring clinical trial NCT01363076?
This trial is sponsored by Egalet, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01363076's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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