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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 is a Phase 3 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 720 participants.

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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.

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

FieldValue
Enrollment Target 720 participants
Start Date 2012-01
Est. Completion 2014-11
Phase Phase 3

Sponsor

Montefiore Medical Center

345 total trials

What the Registry Record Tells You About NCT01402375

The ClinicalTrials.gov registry entry for NCT01402375 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Hydrocodone (first trial) is the first listed.

NCT01402375 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.