Evaluation of Preoperative N1539 in Total Knee Arthroplasty



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:35 - 80
Updated:4/17/2018
Start Date:February 19, 2018
End Date:December 2018
Contact:Stewart McCallum, MD
Email:smccallum@recropharma.com
Phone:484-395-2470

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A Phase 3b, Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Open Unilateral Total Knee Arthroplasty

The primary objective of this study is to assess the effect of preoperative administration of
N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty
compared to placebo.


Inclusion Criteria:

- Voluntarily provide written informed consent.

- Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral
total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an
inpatient setting for ≥24 hours, and receive at least two doses of study drug.

- ASA physical status category 1, 2, or 3.

- Female subjects not pregnant or planning/attempting to become pregnant, not lactating;
or commits to the use of an acceptable form of birth control for the duration of the
study.

- Have a body mass index <40 kg/m^2

Exclusion Criteria:

- Have a known allergy or hypersensitivity to any study treatment.

- Have a history of previous TKA.

- Has plans for a concurrent surgical procedure (eg, bilateral TKA).

- Has TKA planned to be performed under general anesthesia.

- Have a history of myocardial infarction within the preceding 12 months.

- Have, as determined by the investigator or the sponsor's medical monitor, a history or
clinical manifestations of significant condition that would preclude participation.

- Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

- Have a known bleeding disorder which may be worsened with the administration of an
NSAID.

- Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within
48 hours prior to surgery.

- Have previously received N1539/IV meloxicam or received any investigational product
within 30 days before dosing with study medication.

- Have undergone or be expected to undergo radiation therapy, chemotherapy, or other
biological therapy for cancer treatment, within 60 days prior to screening through
last follow-up.
We found this trial at
6
sites
1 Harrison Plaza
Florence, Alabama 35630
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Mobile, Alabama 36608
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Mobile, AL
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1111 South Raleigh Avenue
Sheffield, Alabama 35660
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Sheffield, AL
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4700 State Road 7
Tamarac, Florida 33321
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Tamarac, FL
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2133 E East Warner Road
Tempe, Arizona 85284
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Tempe, AZ
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Vero Beach, Florida 32960
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Vero Beach, FL
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