Pain, Post-operativePhase 3NCT02720692
Evaluation of N1539 Following Major Surgery
A Phase 3 study testing N1539 in people with Pain, Post-operative, run by Baudax Bio at 32 sites in 4 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Post-operative
- What is being tested?
- N1539
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 722 participants
- Where
- 32 sitesin 4 countries
- Study dates
- Mar 2016to May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
United States20 sites
Study site
Anaheim, California, 92801
Study site
Bakersfield, California, 93301
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44111
Study site
Columbus, Ohio, 43210
Study site
Florence, Alabama, 35630
Study site
Gilbert, Arizona, 85295
Study site
Great Falls, Montana, 59405
Study site
Hendersonville, Tennessee, 37075
Study site
Houston, Texas, 77004
Study site
Houston, Texas, 77030
Study site
Miami, Florida, 33136
Study site
Montgomery, Alabama, 36116
Study site
Phoenix, Arizona, 85023
Study site
Salt Lake City, Utah, 84124
Study site
San Antonio, Texas, 78229
Study site
Sheffield, Alabama, 35660
Study site
Tamarac, Florida, 33321
Study site
Tampa, Florida, 33605
Study site
Tyrone, Pennsylvania, 16686
Canada5 sites
Study site
Halifax, Nova Scotia, B#H2Y
Study site
Kingston, Ontario, K7L2V7
Study site
Montreal, Quebec, H1T2M4
Study site
Montreal, Quebec, H4A3J1
Study site
Toronto, Ontario, M5T2S8
Australia4 sites
Study site
Chermside, Queensland, 4032
Study site
Kippa-Ring, Queensland, 4021
Study site
Richmond, Victoria, 3121
Study site
Southport, Queensland, 4215
New Zealand3 sites
Study site
Auckland
Study site
Christchurch, 8024
Study site
Hamilton, 3206
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.
- Conditions
- Pain, Post-operative
- Being tested
- N1539, Intravenous Placebo
- Keywords
- Pain, Analgesia, N1539, Phase 3
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1539Drug
Also called Intravenous meloxicam
Intravenous PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| N1539 30mg | Experimental | N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses. Receives: Drug: N1539 |
| IV Placebo | Placebo comparator | IV Placebo every 24 hours for up to 7 doses. Receives: Drug: Intravenous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events
Number of subjects reporting 1 or more treatment-emergent adverse events
Measured: 28 Days
Secondary outcomes (2)
Investigator Satisfaction With Surgical Wound Healing
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).
Measured: Up to 7 days after last study dose
Postoperative Opioid Use
Postoperative opioid use was measured throughout the inpatient phase and converted to the total IV morphine equivalent dose
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, Post-operativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baudax Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720692
- Sponsor's protocol ID
- REC-15-017
- Status last verified
- May 2023
- First submitted
- 22 Mar 2016
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32021411Bergese 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.
PubMed 30786162Viscusi 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.
PubMed 30737315
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
- ClinicalTrials.gov ID
- NCT02720692
- Acronym / sponsor ID
- REC-15-017
- Conditions
- Pain, Post-operative
- Keywords
- Pain, Analgesia, N1539, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Baudax BioIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Posted 25 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N1539 30mg | Experimental | Drug: N1539N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses. |
| IV Placebo | Placebo comparator | Drug: Intravenous PlaceboIV Placebo every 24 hours for up to 7 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Have a body mass index ≤40 kg/m2
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N1539Also: Intravenous meloxicam | Drug | N1539 30mg |
| Intravenous Placebo | Drug | IV Placebo |
Primary outcome
Number of Subjects With Adverse Events
Time frame: 28 Days
Number of subjects reporting 1 or more treatment-emergent adverse events
2 secondary outcomes
Investigator Satisfaction With Surgical Wound Healing
Time frame: Up to 7 days after last study dose
Postoperative Opioid Use
Time frame: Up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32021411Sharpe 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.
- Derived from this study: PubMed 30786162Bergese 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.
- Derived from this study: PubMed 30737315Viscusi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N1539 in people with Pain, Post-operative, run by Baudax Bio at 32 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.