Post Operative PainPhase 4NCT05315479
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
A Phase 4 study testing N1539 in people with Post Operative Pain, run by Baudax Bio at 3 sites in United States.
Trial summary
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- N1539
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Feb 2022to 7 Jul 2022
- Phase
- Phase 4
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 2 to <17 years of age before dosing on Day 1
- Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia
- Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential
- Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent
Who cannot join
- Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539
- Have a known bleeding disorder that may be worsened with the administration of an NSAID
- Be undergoing cardiothoracic surgery
- Has used meloxicam within 7 days before the surgical procedure on Day 1
- Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Center
Bakersfield, California, 93301
Research Center
Salt Lake City, Utah, 84107
Research Center
Sheffield, Alabama, 35660
About this study
Official title: A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.
- Conditions
- Post Operative Pain
- Being tested
- N1539
- Keywords
- meloxicam, pediatric
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1539Drug
Also called Meloxicam IV
Once daily
| Study group | Role | What they receive |
|---|---|---|
| N1539 | Experimental | N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H Receives: Drug: N1539 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing an AE
Number of study subjects who experienced an AE
Measured: Through study completion, approximately 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start24 Feb 2022
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Why it stopped: Anjeso (N1539) NDA Withdrawn
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.
- Other trials for Post Operative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT05315479
- Sponsor's protocol ID
- BDX-20-002
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2022
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
- ClinicalTrials.gov ID
- NCT05315479
- Acronym / sponsor ID
- BDX-20-002
- Conditions
- Post Operative Pain
- Keywords
- meloxicam, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Anjeso (N1539) NDA Withdrawn
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Baudax BioIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N1539 | Experimental | Drug: N1539N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female 2 to <17 years of age before dosing on Day 1
- Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia
- Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential
- Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent
Key exclusion criteria (5 listed)
- Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539
- Have a known bleeding disorder that may be worsened with the administration of an NSAID
- Be undergoing cardiothoracic surgery
- Has used meloxicam within 7 days before the surgical procedure on Day 1
- Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.
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: Meloxicam IVOnce daily | Drug | N1539 |
Primary outcome
Number of Subjects Experiencing an AE
Time frame: Through study completion, approximately 28 Days
Number of study subjects who experienced an AE
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N1539 in people with Post Operative Pain, run by Baudax Bio at 3 sites in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 13 Sep 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 Experiencing an AE (time frame: Through study completion, approximately 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.