Evaluation of Preoperative N1539 in Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434275
• Other study ID #: REC-17-025
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2018
• Est. completion date: May 21, 2019

Study information

• Verified date: April 2023
• Source: Baudax Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: May 21, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• N1539
Once Daily
• Placebo
Once Daily

Locations

Country	Name	City	State
United States	Research Center	Florence	Alabama
United States	Research Center	Mobile	Alabama
United States	Research Center	Sheffield	Alabama
United States	Research Center	Tamarac	Florida
United States	Research Center	Tempe	Arizona
United States	Research Center	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baudax Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use Hour 0-24	Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.	Up to 24 Hours