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NCT01819610 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures
A Phase 3 study of Pain, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01819610: Completed Phase 3 study of Pain, sponsored by American Regent.
NCT01819610 is a Phase 3 study of Pain that has completed, run by American Regent. The registered enrollment target is 60 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819610, a Phase 3 study of Pain, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety and efficacy of SPRIX.
Conditions Studied
Interventions
- DRUG SPRIX
Study Locations (1)
Pennsylvania
- Luitpold Pharmaceuticals, Inc. - Norristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01819610 record still lists
NCT01819610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 1 intervention - of which SPRIX is the first listed.
NCT01819610 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01819610 about?
NCT01819610 is a clinical study titled "Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures". A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety and efficacy of SPRIX.
What is the current status of trial NCT01819610?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2013-02. Estimated completion is 2014-08.
What conditions does trial NCT01819610 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01819610?
The interventions under investigation include: SPRIX (DRUG).
Who is sponsoring clinical trial NCT01819610?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01819610 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01819610's enrollment target sits among peer trials
60 224th of 374 higher than 134 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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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