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NCT01322360 · ClinicalTrials.gov registry record · Phase 4
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
A Phase 4 study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT01322360 is a Phase 4 study that has completed, run by Roxane Laboratories. The registered enrollment target is 50 participants.
The verdict
NCT01322360, a Phase 4 study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- DRUG Morphine Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01322360
The ClinicalTrials.gov registry entry for NCT01322360 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Morphine Sulfate is the first listed.
NCT01322360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01322360 about?
NCT01322360 is a clinical study titled "Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects". 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. ...
What is the current status of trial NCT01322360?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2011-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01322360?
The interventions under investigation include: Morphine Sulfate (DRUG).
Who is sponsoring clinical trial NCT01322360?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
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