Evaluation of Preoperative N1539 in Colorectal Surgery

A Phase 3 study testing N1539 in people with Pain, Postoperative, run by Baudax Bio at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of Adverse Events (AEs) and Serious AEs (SAEs). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain, Postoperative
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: 57 participants
Where: 10 sitesUnited States
Study dates: 24 Oct 2017to 26 Sep 2018
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.
Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis.
ASA physical status category 1, 2, or 3.
Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
Have a body mass index <40 kg/m^2

Who cannot join

Have a known allergy or hypersensitivity to any study treatment.
Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure.
Have a history of myocardial infarction within the preceding 12 months.
Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with exception of events related to an ulcerative colitis diagnosis.
Have a known bleeding disorder which may be worsened with the administration of an NSAID.

Show all 9Show fewer

Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Research Center
Cleveland, Ohio, 44111
Research Center
Cleveland, Ohio, 44195
Research Center
Columbus, Ohio, 43210
Research Center
Florence, Alabama, 35630
Research Center
Jackson, Mississippi, 39202
Research Center
Metairie, Louisiana, 70006
Research Center
Miami, Florida, 33136
Research Center
Mobile, Alabama, 36605
Research Center
Philadelphia, Pennsylvania, 19140
Research Center
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery

Conditions: Pain, Postoperative
Being tested: N1539, Placebo
Keywords: Colorectal surgery, Pain, Analgesia, N1539, Phase 3b
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
Once Daily
PlaceboDrug
Also called Intravenous placebo
Once Daily

Study groups in NCT03323385
Study group	Role	What they receive
N1539 30 mg	Experimental	N1539 (meloxicam injection for IV use) 30 mg every 24 hours Receives: Drug: N1539
IV Placebo	Placebo comparator	IV Placebo every 24 hours Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Safety and Tolerability - Number of Subjects With an AE
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201726 Sep 2018

First posted27 Oct 2017
Study start24 Oct 2017
Primary completion26 Sep 2018
Study completion26 Sep 2018

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 (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03323385
Sponsor's protocol ID: REC-17-024
Status last verified: May 2023
First submitted: 24 Oct 2017
Last updated: 18 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Silinsky JD, Marcet JE, Anupindi VR, Karkare SU, Shah DR, Mack RJ, McCallum SW, Du W, Freyer A, Black LK. Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis. Pain Manag. 2021 Jan;11(1):9-21. doi: 10.2217/pmt-2020-0061. Epub 2020 Oct 23.
PubMed 33094682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery
ClinicalTrials.gov ID: NCT03323385
Acronym / sponsor ID: REC-17-024
Conditions: Pain, Postoperative
Keywords: Colorectal surgery, Pain, Analgesia, N1539, Phase 3b
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Baudax BioIndustry (pharma, biotech, devices)
Study start: 24 Oct 2017 (actual)
Primary completion: 26 Sep 2018 (actual)
Study completion: 26 Sep 2018 (actual)
First posted: 27 Oct 2017 (actual)
Results: Posted 18 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 30 mg	Experimental	Drug: N1539N1539 (meloxicam injection for IV use) 30 mg every 24 hours
IV Placebo	Placebo comparator	Drug: PlaceboIV Placebo every 24 hours

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Voluntarily provide written informed consent.
Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis.
ASA physical status category 1, 2, or 3.
Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
Have a body mass index <40 kg/m^2

Key exclusion criteria (9 listed)

Have a known allergy or hypersensitivity to any study treatment.
Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure.
Have a history of myocardial infarction within the preceding 12 months.
Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
Have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with exception of events related to an ulcerative colitis diagnosis.

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 meloxicamOnce Daily	Drug	N1539 30 mg
PlaceboAlso: Intravenous placeboOnce Daily	Drug	IV Placebo

Primary outcome

Evaluation of Safety and Tolerability - Number of Subjects With an AE
Time frame: Up to 30 days
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery

Results and safety

Results posted to the registry on 18 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N1539 30 mg	27	26
IV Placebo	30	27

Primary outcome: Evaluation of Safety and Tolerability - Number of Subjects With an AE

Time frame: Up to 30 days. Number. Unit: participants

Measure	N1539 30 mg n = 27	IV Placebo n = 28
Value	23	26

Population analysed: All randomized subjects

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N1539 30 mg	3 of 27 (11.1%)	11 of 27 (40.7%)	0 of 27
IV Placebo	4 of 28 (14.3%)	17 of 28 (60.7%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33094682Silinsky JD, Marcet JE, Anupindi VR, Karkare SU, Shah DR, Mack RJ, McCallum SW, Du W, Freyer A, Black LK. Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis. Pain Manag. 2021 Jan;11(1):9-21. doi: 10.2217/pmt-2020-0061. Epub 2020 Oct 23.
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.

10 sites in 1 country: 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, Postoperative, run by Baudax Bio at 10 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 5 inclusion and 9 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 18 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 10 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. 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 18 Jun 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?

Evaluation of Safety and Tolerability - Number of Subjects With an AE (time frame: Up to 30 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 NCT03323385, which also lists 1 linked publication.

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 18 Jun 2023.