CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 720 enrolled
Drug / intervention
Hydrocodone (first trial) +5 moredrug
Likely dose
Hydrocodone (first trial) 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01402375
NCT01402375Phase 3Completed

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

Montefiore Medical Center·interventional·Posted Jul 26, 2011·Updated May 1, 2018

In Brief

A Phase 3 clinical trial evaluating Hydrocodone (first trial), Codeine (first trial), and 4 other interventions for Analgesia After ED Discharge for Extremity Injuries. Completed, enrolled 720 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartJan 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.9 years ago

Interventions

Hydrocodone (first trial)drug

Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine (first trial)drug

Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone (for second trial)drug

Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine (for second trial)drug

Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone (third trial)drug

Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone (third trial)drug

Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.