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.

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Percocet; Drug: Xartemis

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Resarch,LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percocet; Oxycodone/APAP (acetaminophen)	Drug: Percocet; 10mg/650mg; Other Names: Oxycodone/APAP(acetaminophen)
Active Comparator: Xartemis	Drug: Xartemis; 15mg/650mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non Inferiority	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.	48 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Assessment	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.	120 Hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Professional Global Assessment	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.	48 Hours
Healthcare Professional Global Assessment	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.	120 Hours

Collaborators and Investigators

• Sponsor: Lotus Clinical Research, LLC
• Collaborators: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Oxycodone
• Other Study ID Numbers: LCR-MNK-01C