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An Open Label, Prospective Study of the Analgesic Efficacy of Oral Xartemis Compared to Generic Oxycodone/APAP( Acetaminophen) in the Treatment of Moderate to Severe Post Operative Pain.

NCT02101476 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-04-09

No results posted yet for this study

Summary

The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute moderate to severe post operative pain to generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.

Conditions

  • Post Operative Pain

Interventions

DRUG

Percocet

10mg/650mg

DRUG

Xartemis

15mg/650mg

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Lotus Clinical Research, LLC

    lead OTHER

Principal Investigators

  • Neil Singla, MD · Lotus Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101476 on ClinicalTrials.gov