Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01676493
Status:
TERMINATED
Last Update Posted:
2018-10-02
First Post:
2012-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain
Sponsor:
Roxane Laboratories
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, Safety and Pharmacokinetic Study of Oral Codeine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Post-procedural Pain
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision to stop study due to low recruitment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
Detailed Description:
Eligible pediatric subjects will complete all screening procedures within 14 days before the scheduled procedure. Screening will be permitted on the day of the procedure. At screening, the subject's parent or guardian will provide written parental permission/informed consent to participate in the study and subjects will provide assent (if required by the local Institutional Review Board \[IRB\]) before any protocol-specified procedures or assessments are performed.
Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will undergo procedures expected to result in at least mild to moderate post-procedure pain with the day of the procedure noted as Day 0, and will be followed until discharge from the study site.
Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will undergo procedures expected to result in at least mild to moderate post-procedure pain with the day of the procedure noted as Day 0, and will be followed until discharge from the study site.
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?: