Disorder of KneePhase 4NCT02391844
Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
A Phase 4 study testing Oxycodone in people with Disorder of Knee, run by International Clinical Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disorder of Knee
- What is being tested?
- Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
International Clinical Research Institute
Overland Park, Kansas, 66210
About this study
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
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.
Read the 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
- Conditions
- Disorder of Knee
- Being tested
- Oxycodone
- Keywords
- Knee, Post-Operative Pain, Xartemis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Xartemix XR
Oxycodone with Acetaminophen Extended Release
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Other | Xartemis XR - Oxycodone with Acetaminophen Extended Release Tablet Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Secondary outcomes (1)
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
Measured: Screening to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Srinivas Nalamachu, MD, Principal investigator, International Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391844
- Sponsor's protocol ID
- MNK795-ICRI-001
- Status last verified
- Nov 2015
- First submitted
- 15 May 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02391844
- Acronym / sponsor ID
- MNK795-ICRI-001
- Conditions
- Disorder of Knee
- Keywords
- Knee, Post-Operative Pain, Xartemis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- International Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Other | Drug: OxycodoneXartemis XR - Oxycodone with Acetaminophen Extended Release Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodoneAlso: Xartemix XROxycodone with Acetaminophen Extended Release | Drug | Oxycodone |
Primary outcome
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.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Screening to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas Nalamachu, MD principal investigator
International Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone in people with Disorder of Knee, run by International Clinical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain Scores on the Numerical Rating Scale (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.