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SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures

NCT02102516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-03-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.

Conditions

Interventions

DRUG

SPRIX(intranasal ketorolac tromethamine)

Dose: Subjects weighing 3.0 kg received 3.15 mg (1 spray/1 nostril), subjects weighing 5.1 - 10.0 kg received 5.25 mg (1 spray/1 nostril), subjects weighing 10.1 - 15.4 kg received 10.5 mg (1 spray/1 nostril), subjects weighing 15.5 - 31.7 kg received 15.75 mg (1 spray/1 nostril), and subjects weighing \>=31.8 kg received 31.5 mg (1 spray/2 nostrils). Duration of Treatment: Subjects received a dose of SPRIX every 6 hours from the day of surgery until the morning of post-operative Day 2. Dosing may have resumed after final PK assessment of the morning of post-operative Day 3 until post-operative Day 4. A follow-up phone interview took place 14 days after the final dose of study drug.

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Principal Investigators

  • Linda M. Mundy, MD, PhD · American Regent, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-06-30
Completion
2015-07-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102516 on ClinicalTrials.gov