Open-Label Study of Oxycodone/APAP to Treat Post-Operativ... | NCT02391844

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

NCT02391844

Sponsor

International Clinical Research Institute

Status

Completed

Last Update Posted

Jan 7, 2016Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Disorder of Knee

Interventions

Oxycodone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 15, 2014

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2016

Last Update Posted Date

Jan 7, 2016Estimated

Name	Class
Mallinckrodt	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxycodone	Other	Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet	Drug: Oxycodone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	Oxycodone with Acetaminophen Extended Release	Oxycodone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in pain Scores on the Numerical Rating Scale	Change in pain Scores on the Numerical Rating Scale from baseline (before taking the first dose of study medication) through 4 week study participation.	Baseline to Week 4

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Screening to Week 4

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee
Read and understand English and comprehend the procedures associated with participating in a clinical trial.
Signed an IRB approved consent form and HIPAA authorization
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:

Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial
Allergy to Oxycodone or Acetaminophen.
Uncontrolled pain or other pain conditions that may interfere with evaluation
Pregnant women
Women who are trying to become pregnant
Women who are breastfeeding
Patient who is deemed to be medically unstable by the principal investigator
History of Alcohol, opioid or substance abuse in the last 2 yrs
History of sleep apnea that requires CPAP
History of serious respiratory illness
History of Gastric bypass
Prior use of opiates at doses higher than 90mg Morphine equivalent dosing
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Srinivas Nalamachu, MD	International Clinical Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Clinical Research Institute		Overland Park	Kansas	66210	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids