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Completed Phase 3 Interventional Results available

Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge

ClinicalTrials.gov ID: NCT01402375

Public ClinicalTrials.gov record NCT01402375. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 5:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01402375
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Montefiore Medical Center
Other
Enrollment
720 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2011
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014
Last update posted
Apr 30, 2018

2012 – 2014

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Montefiore Medical Center The Bronx New York 10467

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01402375, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2018 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01402375 live on ClinicalTrials.gov.

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