NCT03434275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 25, 2023

Completed
Last Updated

May 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

February 9, 2018

Results QC Date

April 28, 2023

Last Update Submit

April 28, 2023

Conditions

Pain, Postoperative

Keywords

Total Knee ArthroplastyPainAnalgesiaN1539Phase 3bKnee Replacement

Outcome Measures

Primary Outcomes (1)

  • Opioid Use Hour 0-24

    Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.

    Up to 24 Hours

Study Arms (2)

N1539 30 mg

EXPERIMENTAL

N1539 (meloxicam injection for IV use) 30 mg every 24 hours

Drug: N1539

IV Placebo

PLACEBO COMPARATOR

IV Placebo every 24 hours

Drug: Placebo

Interventions

N1539DRUG

Once Daily

Also known as: Intravenous meloxicam
N1539 30 mg
PlaceboDRUG

Once Daily

Also known as: Intravenous placebo
IV Placebo

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Center

Florence, Alabama, 35630, United States

Location

Research Center

Mobile, Alabama, 36608, United States

Location

Research Center

Sheffield, Alabama, 35660, United States

Location

Research Center

Tempe, Arizona, 85284, United States

Location

Research Center

Tamarac, Florida, 33321, United States

Location

Research Center

Vero Beach, Florida, 32960, United States

Location

Related Publications (1)

  • Berkowitz RD, Steinfeld R, Sah AP, Mack RJ, McCallum SW, Du W, Black LK, Freyer A, Coyle E. Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial. Pain Med. 2021 Jun 4;22(6):1261-1271. doi: 10.1093/pm/pnab016.

    PMID: 33502533DERIVED

MeSH Terms

Conditions

Pain, PostoperativePainAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Results Point of Contact

Title
Development
Organization
Baudax Bio, Inc.
info@baudaxbio.com
484-395-2440

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 15, 2018

Study Start

February 19, 2018

Primary Completion

May 21, 2019

Study Completion

May 21, 2019

Last Updated

May 25, 2023

Results First Posted

May 25, 2023

Record last verified: 2023-04

Locations

US(6)