NCT01676493

A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Roxane Laboratories · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Codeine

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-08-31
• Last updated: 2018-10-02

Locations

1 site across 1 country: United States