NCT02720692

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
722

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3

Geographic Reach
4 countries

32 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

Study Start

First participant enrolled

March 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

May 25, 2023

Completed
Last Updated

June 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

March 22, 2016

Results QC Date

April 28, 2023

Last Update Submit

May 25, 2023

Conditions

Pain, Post-operative

Keywords

PainAnalgesiaN1539Phase 3

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Adverse Events

    Number of subjects reporting 1 or more treatment-emergent adverse events

    28 Days

Secondary Outcomes (2)

  • Investigator Satisfaction With Surgical Wound Healing

    Up to 7 days after last study dose

  • Postoperative Opioid Use

    Up to 7 days

Study Arms (2)

N1539 30mg

EXPERIMENTAL

N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses.

Drug: N1539

IV Placebo

PLACEBO COMPARATOR

IV Placebo every 24 hours for up to 7 doses.

Drug: Intravenous Placebo

Interventions

N1539DRUG
Also known as: Intravenous meloxicam
N1539 30mg
Intravenous PlaceboDRUG
IV Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily provide written informed consent.
  • Male or female between 18 and 80 years of age, inclusive.
  • Be planning to undergo major elective surgery, and be expected to require intravenous analgesia and remain in an inpatient setting for at least 24-48 hours and are expected to receive at least two study doses.
  • Female subjects are eligible only if all the following apply:
  • Not pregnant;
  • Not breastfeeding;
  • Not able to become pregnant;
  • Not planning to become pregnant during the study or 28 day follow up;
  • Commit to the use of an acceptable form of birth control for the duration of the study.
  • Have a body mass index ≤40 kg/m2
  • Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
  • For oncology cases, have a histologically confirmed diagnosis of a primary solid tumor, affecting any one of the following organs: breast, skin, colon, prostate, uterus, ovaries, urethra, penis, or vulva; AND based on clinical, laboratory, radiologic, pathologic, and surgical findings, the tumor is confined to the primary organ, without evidence of local, regional or distal spread; AND have a performance status such that they are able to carry on normal activities of daily life without limitations.

You may not qualify if:

  • Have a known allergy to meloxicam or any excipient of N1539, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Be scheduled to undergo cranial surgery, open heart procedure, any type of coronary artery bypass graft, organ transplant, or any other surgical procedure in which NSAIDs are contraindicated.
  • Planned or actual admission to the intensive care unit at any time during study participation.
  • Have clinically significant laboratory abnormalities.
  • Have a history of myocardial infarction within the preceding 12 months.
  • Have history of HIV, or hepatitis B or C.
  • Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, respiratory, or other condition that would preclude participation in the study.
  • Have active or recent (within 6 months) gastrointestinal ulceration or bleeding
  • Have a known bleeding disorder which may be worsened with the administration of a NSAID.
  • Have evidence of a clinically significant 12 lead ECG abnormality.
  • Have a history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or a history of prescription/illicit drug abuse within the past 5 years.
  • Have positive results on the urine drug screen for cocaine or PCP or alcohol breath test indicative of illicit drug or alcohol abuse.
  • Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled surgical procedure, within 5 half-lives of the specific prior medication (or, if half-life is not known, within 48 hours) before dosing with study medication.
  • Be unable to discontinue herbal medications at least 7 days prior to surgery through last dose of study medication.
  • Be receiving lithium, or a combination of furosemide with either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Florence, Alabama, 35630, United States

Location

Unknown Facility

Montgomery, Alabama, 36116, United States

Location

Unknown Facility

Sheffield, Alabama, 35660, United States

Location

Unknown Facility

Gilbert, Arizona, 85295, United States

Location

Unknown Facility

Phoenix, Arizona, 85023, United States

Location

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Bakersfield, California, 93301, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Tamarac, Florida, 33321, United States

Location

Unknown Facility

Tampa, Florida, 33605, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Cleveland, Ohio, 44111, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

Tyrone, Pennsylvania, 16686, United States

Location

Unknown Facility

Hendersonville, Tennessee, 37075, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

Chermside, Queensland, 4032, Australia

Location

Unknown Facility

Kippa-Ring, Queensland, 4021, Australia

Location

Unknown Facility

Southport, Queensland, 4215, Australia

Location

Unknown Facility

Richmond, Victoria, 3121, Australia

Location

Unknown Facility

Halifax, Nova Scotia, B#H2Y, Canada

Location

Unknown Facility

Kingston, Ontario, K7L2V7, Canada

Location

Unknown Facility

Toronto, Ontario, M5T2S8, Canada

Location

Unknown Facility

Montreal, Quebec, H1T2M4, Canada

Location

Unknown Facility

Montreal, Quebec, H4A3J1, Canada

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Christchurch, 8024, New Zealand

Location

Unknown Facility

Hamilton, 3206, New Zealand

Location

Related Publications (3)

  • Sharpe KP, Berkowitz R, Tyndall WA, Boyer D, McCallum SW, Mack RJ, Du W. Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery. J Pain Res. 2020 Jan 21;13:221-229. doi: 10.2147/JPR.S216219. eCollection 2020.

    PMID: 32021411DERIVED

  • Bergese SD, Melson TI, Candiotti KA, Ayad SS, Mack RJ, McCallum SW, Du W, Gomez A, Marcet JE. A Phase 3, Randomized, Placebo-Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery. Clin Pharmacol Drug Dev. 2019 Nov;8(8):1062-1072. doi: 10.1002/cpdd.666. Epub 2019 Feb 20.

    PMID: 30786162DERIVED

  • Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.

    PMID: 30737315DERIVED

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

March 22, 2016

First Posted

March 28, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

June 22, 2023

Results First Posted

May 25, 2023

Record last verified: 2023-05

Locations

US(20)NZ(3)AU(4)CA(5)