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NCT01402375 · ClinicalTrials.gov registry record · Phase 3
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
A Phase 3 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
NCT01402375: Completed Phase 3 study, sponsored by Montefiore Medical Center.
NCT01402375 is a Phase 3 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 720 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01402375, a Phase 3 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
Study Summary
There will be 3 randomized, double-blinded clinical trials to help determine which of commonly prescribed oral opioid combination is most effective in managing acute extremity pain after discharge from the adult emergency department. The first trial compares hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.
Primary Outcome
Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken.
Interventions
- DRUG Hydrocodone (first trial)
- DRUG Codeine (first trial)
- DRUG Oxycodone (for second trial)
- DRUG Codeine (for second trial)
- DRUG Oxycodone (third trial)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01402375 record still lists
NCT01402375 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Hydrocodone (first trial) is the first listed.
NCT01402375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01402375 about?
NCT01402375 is a clinical study titled "Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge". There will be 3 randomized, double-blinded clinical trials to help determine which of commonly prescribed oral opioid combination is most effective in managing acute extremity pain after discharge from the adult emergency department. The first trial compares hydrocodone 5mg / acetaminophen 500mg to ...
What is the current status of trial NCT01402375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 2012-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01402375?
The interventions under investigation include: Hydrocodone (first trial) (DRUG), Codeine (first trial) (DRUG), Oxycodone (for second trial) (DRUG), Codeine (for second trial) (DRUG), Oxycodone (third trial) (DRUG).
Who is sponsoring clinical trial NCT01402375?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01402375's enrollment target sits among peer trials
720 494th of 2000 higher than 1,503 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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