Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01819610
The ClinicalTrials.gov registry entry for NCT01819610 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower). The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
RECRUITING · Phase 3
-
Opioid-Free Orthopaedics
RECRUITING · Phase 3
-
Suzetrigine in Total Hip Arthroplasty
RECRUITING · Phase 3
-
Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
RECRUITING · Phase 3
-
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
RECRUITING · Phase 3
-
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.