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Post-operation PainPhase 2NCT02263222

A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty

A Phase 2 study testing MDT-10013 in people with Post-operation Pain, run by Medtronic Spinal and Biologics at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-operation Pain
What is being tested?
MDT-10013
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Feb 2016to Jun 2016
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is male or female at least 18 years of age
  • Has a body mass index from 18 kg/m2 to 40 kg/m2
  • Is scheduled to undergo standard primary (first-time) unilateral TKA surgery (due to osteoarthritis) with or without patellar resurfacing. Standard conventional instrumentation and cemented components must be used and the surgery shall be conducted under spinal anesthesia.
  • Females must meet the following criteria:
  • Is of nonchildbearing potential, defined as any woman who has undergone surgical sterilization or is more than 2 years postmenopausal
  • If of childbearing potential, may be enrolled if pregnancy test results are negative at Screening and if she is routinely using an effective method of birth control with a low failure rate (i.e., hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, or total sexual abstinence).
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  • May not be pregnant or lactating
  • Has read, understood, and signed the informed consent before study entry
  • Is mentally competent, reliable, and cooperative to undergo all visits and procedures scheduled in the study protocol and to record the required information.

Who cannot join

  • Has had previous spinal surgery or other contraindications that preclude use of spinal anesthesia or is not indicated for surgery because of an inflammatory process or risk of infection or delayed wound healing (e.g., autoimmune disorder)
  • Is scheduled to undergo a concurrent surgical procedure (e.g., bilateral TKA)
  • Has a concurrent painful condition or surgery that may require analgesic treatment (such as a nonsteroidal antiinflammatory drug [NSAID] or opioid) in the postsurgical period for pain not strictly related to the TKA, and that may confound postsurgical assessments
  • Has a history of allergy or hypersensitivity to the components in the investigational product or to the routine care medications
  • Has current orthostatic hypotension (i.e., systolic blood pressure decrease of at least 20 mmHg or diastolic blood pressure decrease of at least 10 mmHg or an increase in heart rate of 20 beats per minute within 3 minutes of standing)
  • Has any clinically significant cardiovascular condition as evidenced by physical examination, medical history, and/or baseline electrocardiogram (ECG), including inadequately controlled hypertension
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  • Has evidence of bradycardia as shown by heart rate of <50 beats per minute via screening ECG
  • In the investigator's opinion, subject is not a suitable candidate for study treatment and/or has any poorly controlled or serious medical conditions, psychiatric illnesses, or clinically significant laboratory values that the investigator suspects could compromise the subject's safety or the scientific integrity of the study (e.g., human immunodeficiency virus [HIV], hepatitis B or C [hep B, hep C])
  • Has presence or history of local or systemic malignant disease in the past 5 years (history of basal cell carcinoma will be allowed)
  • Has undergone prior open surgery in the affected knee
  • Has impaired renal function (creatinine >1.5 times upper limit of normal)
  • Has chronic liver function impairment (aspartate aminotransferase or alanine aminotransferase >3 times upper limit of normal)
  • Has insulin-dependent diabetes or uncontrolled diabetes mellitus (glycosylated hemoglobin >7%)
  • Has leukopenia (<3500 leukocytes/μL)
  • Has current treatment with any of the following medications:
  • Systemic corticosteroids within 1 month of the planned surgery (intranasal/inhaled steroids are acceptable)
  • Immunosuppressant therapy to treat autoimmune diseases (e.g., rheumatoid arthritis, multiple sclerosis, myasthenia gravis, systemic lupus erythematosus, sarcoidosis, focal segmental glomerulosclerosis, Crohn's disease, Behcet's disease, pemphigus, or ulcerative colitis)
  • Oral or topical products containing clonidine (e.g., Catapres®)
  • Antiepileptic drugs, antipsychotics, monoamine oxidase inhibitors, lithium, or sulfonamides
  • Calcium channel blocker, digoxin, or beta-adrenergic blockers
  • Chronically uses opioids, defined as use on at least 20 of the last 30 days before study Screening, and is unable to refrain from opioid use within the 24 hour period before surgery
  • Investigator determines subject has a known or suspected history of drug or alcohol abuse
  • Recent dose adjustment or commencement of treatment with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (use of these medications is allowed if the dose is stable for at least 8 weeks before receiving study treatment)
  • Has received any other investigational drug or device within 30 days of Screening
  • Experiences any surgical complication that, in the investigator's opinion, precludes implantation of MDT-10013.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Clinical Research Department, University of Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Florida Research Associates, LLC

    DeLand, Florida, 32720

Other trials in United States

About this study

Official title: A Feasibility Dose-escalating Study to Evaluate the Tolerability and Systemic Exposure of MDT-10013 Plus Routine Care in the Treatment of Acute Postoperative Pain Following Total Knee Arthroplasty

This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.

Being tested
MDT-10013

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDT-10013Drug

Study groups in NCT02263222
Study groupRoleWhat they receive
MDT-10013ExperimentalSubjects will receive MDT-10013.
Receives: Drug: MDT-10013

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic (PK) parameters of MDT-10013--maximum plasma concentration observed (Cmax)

    Measured: From day 1 to day 14

  2. Pharmacokinetic (PK) parameters of MDT-10013--time to maximum plasma concentration observed (tmax)

    Measured: From day 1 to day 14

  3. Pharmacokinetic (PK) parameters of MDT-10013--area under the plasma concentration versus time curve (AUC)

    Measured: From day 1 to day 14

  4. Rate of study drug/treatment-related serious adverse events (SAEs)

    Measured: up to 3 months

Secondary outcomes (6)

  1. Summed pain intensity scores at rest

    Summed pain intensity scores (calculated as a time-weighted average) by using an 11-point (0 to 10) numerical rating scale (NRS).

    Measured: up to 120 hours

  2. Summed pain intensity scores over 2 to 48 hours (SPI-48) with activity

    Measured: up to 48 hours

  3. Aggregate dosage of all opioid analgesia

    Measured: 0 to 24 hours and 0 to 48 hours

  4. Total use of opioid analgesia

    Measured: From 48 hours through Day 6/120 hours

  5. Time to first use of opioid analgesia defined as the time from Time 0 to the first use of opioid analgesia.

    Measured: Time 0 is defined as the initiation of arthrotomy closure to the first opioid analgesia use

  6. Subject global evaluation of study treatment

    Measured: up to 10-14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2014 (estimated)
  2. Study startFeb 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02263222
Sponsor's protocol ID
P13-02
Status last verified
Jun 2016
First submitted
30 Sep 2014
Last updated
7 Jun 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MDT-10013 in people with Post-operation Pain, run by Medtronic Spinal and Biologics at 3 sites 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 9 inclusion and 25 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: withdrawn, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Pharmacokinetic (PK) parameters of MDT-10013--maximum plasma concentration observed (Cmax) (time frame: From day 1 to day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263222.

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 Jun 2016.

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