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Study of Oral Morphine Sulfate Administration in Pediatric Subjects

NCT03429400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-09-26

No results posted yet for this study

Summary

This is a multicenter, open-label study to evaluate the safety and PK of oral morphine sulfate in pediatric subjects with post-operative pain.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Morphine Sulfate

Morphine every 4 hours as needed for up to a maximum of 5 days

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • West-Ward Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Susanne Schmidt, MD,PhD · Premier Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2019-05-29
Completion
2019-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03429400 on ClinicalTrials.gov