Trials / Completed
CompletedNCT01322360
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Morphine Sulfate |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2011-03-24
- Last updated
- 2018-02-05
- Results posted
- 2014-05-23
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01322360. Inclusion in this directory is not an endorsement.