drugset / Trial / NCT01402375

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

NCT01402375

Phase 3 Completed 720 enrolled Montefiore Medical Center
RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start
2012-01
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 300 mg Oral
Subject Acetaminophen Small molecule 325 mg Oral
Subject Acetaminophen Small molecule 500 mg Oral
Comparator Codeine Small molecule 30 mg Oral
Subject Hydrocodone Unknown 5 mg Oral
Subject Oxycodone Other / unclassified 5 mg Oral

Indications

No indication recorded.