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Trial record 45 of 665 for:    OXYCODONE

Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery

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ClinicalTrials.gov Identifier: NCT02391844
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
International Clinical Research Institute

Brief Summary:
This is a pilot trial using this product in patients for the management of pain after outpatient arthroscopic knee surgery. This is an open-label study and the two active ingredients are well known pharmacologic entities.

Condition or disease Intervention/treatment Phase
Disorder of Knee Drug: Oxycodone Phase 4

Detailed Description:

The objective of this single center is to evaluate the safety and efficacy of Oxycodone Extended Release (MNK-795) in postoperative pain following common musculoskeletal surgical procedures. Knee surgery being the most common surgery performed in the US, the investigators chose the model. The investigators also want to look at the flexible-dosing and titration which is the common way pain managed by clinicians. This is an open-label study of MNK 795 to be described in the procedures section.

Primary endpoint:

• Change in pain from baseline (before taking the first dose of study medication) measured on NRS

Secondary endpoints:

  • Patient/Investigator Global assessment of treatment satisfaction
  • Safety evaluation with adverse event monitoring

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Parallel Group Flexible Dosing & Titration Study to Evaluate the Efficacy, Safety of Oxycodone/APAP Extended Release Formulation Xartemisxr® in the Management of Post-Operative Pain Following Outpatient Arthroscopic Knee Surgery
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Oxycodone
Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet
Drug: Oxycodone
Oxycodone with Acetaminophen Extended Release
Other Name: Xartemix XR




Primary Outcome Measures :
  1. Change in pain Scores on the Numerical Rating Scale [ Time Frame: Baseline to Week 4 ]
    Change in pain Scores on the Numerical Rating Scale from baseline (before taking the first dose of study medication) through 4 week study participation.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Screening to Week 4 ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability


Other Outcome Measures:
  1. Assessment of Treatment Satisfaction [ Time Frame: 1 Week, 2 Weeks, and 4 Weeks Post Dose ]
    Patient/Investigator Global assessment of treatment satisfaction will be completed 3 follow-up visits after screening.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee
  2. Read and understand English and comprehend the procedures associated with participating in a clinical trial.
  3. Signed an IRB approved consent form and HIPAA authorization
  4. Patients with a pain intensity score of 4 or above on the 0-10 numerical rating scale (0 is no pain, 10 is the worst pain imaginable)

Exclusion Criteria:

  1. Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial
  2. Allergy to Oxycodone or Acetaminophen.
  3. Uncontrolled pain or other pain conditions that may interfere with evaluation
  4. Pregnant women
  5. Women who are trying to become pregnant
  6. Women who are breastfeeding
  7. Patient who is deemed to be medically unstable by the principal investigator
  8. History of Alcohol, opioid or substance abuse in the last 2 yrs
  9. History of sleep apnea that requires CPAP
  10. History of serious respiratory illness
  11. History of Gastric bypass
  12. Prior use of opiates at doses higher than 90mg Morphine equivalent dosing
  13. Will limit the study medication to 4 tab at each dosing and to total dose of 8 tab for 24 hrs. Subjects needing doses higher than that, based on their current opioid dose, will not be enrolled or discontinued

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): NCT02391844


Locations
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United States, Kansas
International Clinical Research Institute
Overland Park, Kansas, United States, 66210
Sponsors and Collaborators
International Clinical Research Institute
Mallinckrodt
Investigators
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Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute

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Responsible Party: International Clinical Research Institute
ClinicalTrials.gov Identifier: NCT02391844     History of Changes
Other Study ID Numbers: MNK795-ICRI-001
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: November 2015
Keywords provided by International Clinical Research Institute:
Knee
Post-Operative Pain
Xartemis
Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents