Trials / Completed
CompletedNCT03429400
Study of Oral Morphine Sulfate Administration 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 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- West-Ward Pharmaceutical · 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 morphine sulfate in pediatric subjects with post-operative pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Morphine Sulfate | Morphine every 4 hours as needed for up to a maximum of 5 days |
Timeline
- Start date
- 2018-04-17
- Primary completion
- 2019-05-29
- Completion
- 2019-05-29
- First posted
- 2018-02-12
- Last updated
- 2019-09-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03429400. Inclusion in this directory is not an endorsement.