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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: Completed Phase 4 study, sponsored by Roxane Laboratories.
NCT01322360 is a Phase 4 study that has completed, run by Roxane Laboratories. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade. Additional secondary endpoints were the incidence, type, relationship to study dr
Interventions
- DRUG Morphine Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01322360 record still lists
NCT01322360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Morphine Sulfate is the first listed.
NCT01322360 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01322360's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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