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Trial record 45 of 672 for:    OXYCODONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date January 7, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02391844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2015)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
Official Title  ICMJE 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
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Disorder of Knee
Intervention  ICMJE Drug: Oxycodone
Oxycodone with Acetaminophen Extended Release
Other Name: Xartemix XR
Study Arms  ICMJE Oxycodone
Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet
Intervention: Drug: Oxycodone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
40
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02391844
Other Study ID Numbers  ICMJE MNK795-ICRI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Clinical Research Institute
Study Sponsor  ICMJE International Clinical Research Institute
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute
PRS Account International Clinical Research Institute
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP