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 | Completed Phase 4

• 1 other identifier: LCR-MNK-01C
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Assessment

  120 Hours

Other Outcomes (2)

• Healthcare Professional Global Assessment

  48 Hours

• Healthcare Professional Global Assessment

  120 Hours

Study Arms (2)

Percocet

ACTIVE COMPARATOR

Oxycodone/APAP (acetaminophen)

Drug: Percocet

Xartemis

ACTIVE COMPARATOR

Drug: Xartemis

Interventions

Percocet DRUG

10mg/650mg

Also known as: Oxycodone/APAP(acetaminophen)

Percocet

Xartemis DRUG

15mg/650mg

Xartemis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lotus Clinical Research, LLC: lead
• Mallinckrodt: collaborator

Study Sites (1)

Lotus Clinical Resarch,LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Neil Singla, MD

  Lotus Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 2, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)