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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02720692




Registration number
NCT02720692
Ethics application status
Date submitted
22/03/2016
Date registered
28/03/2016

Titles & IDs
Public title
Evaluation of N1539 Following Major Surgery
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
Secondary ID [1] 0 0
REC-15-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Post-operative 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Adverse Events
Timepoint [1] 0 0
28 Days
Secondary outcome [1] 0 0
Investigator Satisfaction With Surgical Wound Healing
Timepoint [1] 0 0
Up to 7 days after last study dose
Secondary outcome [2] 0 0
Postoperative Opioid Use
Timepoint [2] 0 0
Up to 7 days

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
722
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Chermside
Recruitment hospital [2] 0 0
- Kippa-Ring
Recruitment hospital [3] 0 0
- Southport
Recruitment hospital [4] 0 0
- Richmond
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Montana
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Christchurch
Country [17] 0 0
New Zealand
State/province [17] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Baudax Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02720692