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Completed

NCT Number: NCT02101476

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lotus Clinical Resarch,LLC

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who provide written informed consent prior to enrollment
  • Male or female and 18 years of age or older.
  • Patients who are scheduled to undergo elective general surgery including, but not limited to the following surgical types:
  • Abdominal surgery
  • Orthopedic surgery
  • Spine surgery
  • Genitourinary surgery
  • Patient classified as American Society of Anesthesiologists (ASA class I-III).
  • Female subjects are eligible only if all of the following apply:
  • Not pregnant (subjects of child bearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test before surgery);
  • Not lactating;
  • Not planning to become pregnant within the duration of the study;
  • Patients who are expected to have acute pain requiring oral opioid analgesics for at least 48 hours during the post operative period (either inpatient or outpatient).
  • Patient must report a categorical pain rating of moderate to severe on a scale of none, mild, moderate, or severe prior to randomization.
  • Patients who are willing and capable of understanding and cooperating with the requirements of the study.
  • Patients able to understand and communicate in English.

Exclusion criteria

  • Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, or any other clinically significant medical condition that may preclude safe study participation
  • Patients who have a known severe allergy or hypersensitivity to opioid analgesics, anesthetics, APAP (acetaminophen.)
  • Patients who have a history of intolerance to short term opioid use.
  • Patients who have abused any prescription medication or alcohol within two years before the start of the study.
  • Patients who require an additional scheduled surgical procedure within 48 hours of the surgery.
  • Patients who have a history of seizures, or are currently taking anticonvulsants.
  • Patients who have dysphagia and/or cannot swallow study medication whole.
  • Patient who is unable to adequately communicate with study staff, properly give informed consent, or otherwise comply with study procedures.
  • Patient who has participated in another clinical trial of an investigational drug or device within 30 days of screening visit or is schedule to receive an investigational product while participating in the study.

Post operative Exclusion Criteria at Randomization:

  • Patients who are not awake, not breathing spontaneously, or have a respiratory insufficiency.
  • Patients who are vomiting and not responsive to standard treatment
  • Patients not able to answer questions and follow commands.
  • Patients who have surgical complications that could compromise safety of the subject or confound the results of the study.

Treatment and study plan

Percocet

Drug

10mg/650mg

Other names: Oxycodone/APAP(acetaminophen)

Xartemis

Drug

15mg/650mg

Primary outcomes

  1. Non Inferiority

    Time frame: 48 Hours

    To demonstrate the non inferiority of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute post operative pain when compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours. The statistical comparison of interest will be the patient global assessment of analgesic effect administered at 48 hours after treatment initiation.

Secondary outcomes

  1. Patient Global Assessment

    Time frame: 120 Hours

    To assess patient global assessments at 120 hours after treatment initiation for Xartemis 15mg/650mg by mouth every 12 hours compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours.

Other outcomes

  1. Healthcare Professional Global Assessment

    Time frame: 48 Hours

    To assess healthcare professional global assessments at 48 hours and 120 hours after treatment initiation for Xartemis 15mg/650mg by mouth every 12 hours compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours.

  2. Healthcare Professional Global Assessment

    Time frame: 120 Hours

    To assess healthcare professional global assessments at 48 hours and 120 hours after treatment initiation for Xartemis 15mg/650mg by mouth every 12 hours compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours.

Sponsors and collaborators

Lead sponsor

Lotus Clinical Research, LLC

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

A Randomized, 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2014
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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