Clinical trial NCT02720692: Evaluation of N1539 Following Major Surgery
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Post-operative
Keywords: Pain
Analgesia
N1539
Phase 3
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2016-03-28
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Be currently receiving treatment with oral meloxicam (Mobic®) or other NSAID within 7 days prior to surgery.
* Have received any investigational product within 30 days before dosing with study medication.
* Have previously received N1539 in clinical trials, or had major surgery in the last 3 months that would interfere with study assessments.
* Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening, through the last study visit, approximately 30 days after dosing.

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: 28 Days
Secondary outcomes:
measure: Investigator Satisfaction With Surgical Wound Healing
timeFrame: Up to 7 days after last study dose
measure: Postoperative Opioid Use
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Florence
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Sheffield
country: United States
state: Alabama
city: Gilbert
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Great Falls
country: United States
state: Montana
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Tyrone
country: United States
state: Pennsylvania
city: Hendersonville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Chermside
country: Australia
state: Queensland
city: Kippa-Ring
country: Australia
state: Queensland
city: Southport
country: Australia
state: Queensland
city: Richmond
country: Australia
state: Victoria
city: Halifax
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.