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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02720692
Registration number
NCT02720692
Ethics application status
Date submitted
22/03/2016
Date registered
28/03/2016
Date last updated
22/06/2023
Titles & IDs
Public title
Evaluation of N1539 Following Major Surgery
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
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Secondary ID [1]
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REC-15-017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain, Post-operative
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - N1539
Treatment: Drugs - Intravenous Placebo
Experimental: N1539 30mg - N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses.
Placebo Comparator: IV Placebo - IV Placebo every 24 hours for up to 7 doses.
Treatment: Drugs: N1539
Treatment: Drugs: Intravenous Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Adverse Events
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Assessment method [1]
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Number of subjects reporting 1 or more treatment-emergent adverse events
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Timepoint [1]
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28 Days
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Secondary outcome [1]
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Investigator Satisfaction With Surgical Wound Healing
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Assessment method [1]
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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 (worse outcome), and a score of 10 was completely satisfied (better outcome).
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Timepoint [1]
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Up to 7 days after last study dose
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Secondary outcome [2]
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Postoperative Opioid Use
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Assessment method [2]
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Postoperative opioid use was measured throughout the inpatient phase and converted to the total IV morphine equivalent dose
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Timepoint [2]
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Up to 7 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2017
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Sample size
Target
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Accrual to date
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Final
722
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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- Chermside
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Recruitment hospital [2]
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- Kippa-Ring
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Recruitment hospital [3]
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- Southport
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Recruitment hospital [4]
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- Richmond
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Recruitment postcode(s) [1]
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4032 - Chermside
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Recruitment postcode(s) [2]
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4021 - Kippa-Ring
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Florida
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Illinois
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Montana
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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State/province [17]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Baudax Bio
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of N1539 in a
variety of post-surgical conditions.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02720692
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02720692
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