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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 is a Phase 1 study that has completed, run by Egalet. The registered enrollment target is 20 participants.
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.
Interventions
- DRUG Ketorolac Tromethamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363076
The ClinicalTrials.gov registry entry for NCT01363076 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Egalet, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketorolac Tromethamine is the first listed.
NCT01363076 reports 0 study locations.
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.
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