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Trial record 57 of 663 for:    OXYCODONE

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.

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ClinicalTrials.gov Identifier: NCT02101476
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Lotus Clinical Research, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Percocet Drug: Xartemis Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Percocet
Oxycodone/APAP (acetaminophen)
Drug: Percocet
10mg/650mg
Other Name: Oxycodone/APAP(acetaminophen)

Active Comparator: Xartemis Drug: Xartemis
15mg/650mg




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101476


Locations
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United States, California
Lotus Clinical Resarch,LLC
Pasadena, California, United States, 91105
Sponsors and Collaborators
Lotus Clinical Research, LLC
Mallinckrodt
Investigators
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Principal Investigator: Neil Singla, MD Lotus Clinical Research, LLC

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Responsible Party: Lotus Clinical Research, LLC
ClinicalTrials.gov Identifier: NCT02101476     History of Changes
Other Study ID Numbers: LCR-MNK-01C
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Lotus Clinical Research, LLC:
Pain
Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents