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NCT01676493 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain
A Phase 3 study, sponsored by Roxane Laboratories.
- Terminated
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT01676493: Clinical Trial Phase 3 study, sponsored by Roxane Laboratories.
NCT01676493 is a Phase 3 study that was terminated before completion, run by Roxane Laboratories. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01676493, a Phase 3 study, was terminated before completion, sponsored by Roxane Laboratories.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
Primary Outcome
* Percentage of subjects who experience any AEs with a causal relationship to the study medication characterized as possible, probable or unknown (unable to judge). * Percentage of subjects with SAEs. * Percentage of subjects with a UMSS sedation score of 4.
Interventions
- DRUG Codeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
Why NCT01676493 stopped before completion
NCT01676493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Codeine is the first listed.
NCT01676493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01676493 about?
NCT01676493 is a clinical study titled "A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain". This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
What is the current status of trial NCT01676493?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2012-04. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01676493?
The interventions under investigation include: Codeine (DRUG).
Who is sponsoring clinical trial NCT01676493?
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 NCT01676493's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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