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Evaluation of N1539 Following Major Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02720692
Recruitment Status : Completed
First Posted : March 28, 2016
Results First Posted : May 25, 2023
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Baudax Bio

Tracking Information
First Submitted Date  ICMJE March 22, 2016
First Posted Date  ICMJE March 28, 2016
Results First Submitted Date  ICMJE April 28, 2023
Results First Posted Date  ICMJE May 25, 2023
Last Update Posted Date May 25, 2023
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2023)		 Number of Subjects With Adverse Events [ Time Frame: 28 Days ]
Number of subjects reporting 1 or more treatment-emergent adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)		 Number of subjects with adverse events [ Time Frame: 28 Days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2023)
  • Investigator Satisfaction With Surgical Wound Healing [ Time Frame: Up to 7 days after last study dose ]
    Investigators assessed their satisfaction with the healing of the surgical wound according to an 11-point numeric rating scale (0-10) where a score of 0 was completely unsatisfied, and a score of 10 was completely satisfied.
  • Postoperative Opioid Use [ Time Frame: Up to 7 days ]
    Postoperative opioid use was measured throughout the inpatient phase and converted to the total IV morphine equivalent dose
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of N1539 Following Major Surgery
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
Brief Summary The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Post-operative
Intervention  ICMJE
  • Drug: N1539
    Other Name: Intravenous meloxicam
  • Drug: Intravenous Placebo
Study Arms  ICMJE
  • Experimental: N1539 30mg
    N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses.
    Intervention: Drug: N1539
  • Placebo Comparator: IV Placebo
    IV Placebo every 24 hours for up to 7 doses.
    Intervention: Drug: Intravenous Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2017)		 722
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2016)		 700
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02720692
Other Study ID Numbers  ICMJE REC-15-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Baudax Bio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Baudax Bio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Baudax Bio
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP