Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects

Diseases and Conditions Researched

Pain

What is the purpose of this trial?

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.



Participation Guidelines

Age: 2 Years - 17 Years
Gender: Both

Click here for detailed participation information for this trial.

Sponsor: Roxane Laboratories
Dates: March 21, 2011
Last Updated: April 2, 2012
Study HIC#: 1103008195
Clinicaltrials.gov ID: NCT01322360