Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT01322360
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
Sponsor:
Roxane Laboratories
Organization:
Study Overview
Official Title:
A Multicenter, Open Label, Safety and Pharmacokinetic Study of Oral Morphine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Postoperative Pain
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration.
To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.
To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.
To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.
To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: