A Phase 3 interventional study of N1539 and Placebo in Pain, Postoperative, sponsored by Baudax Bio. Completed at 6 sites in United States. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Baudax Bio · Phase 3, Interventional, and Treatment
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Among 24 studies testing meloxicam in Pain, Postoperative — 2 open to participants now, 3 under way, none of them phase 3. Meloxicam · Pain, Postoperative.
Among the 24 studies testing meloxicam in Pain, Postoperative, this one is the 11th largest by enrollment, is one of 3 that started in 2018, is one of 9 in phase 3, and was the 11th registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →2 of the 24 studies testing meloxicam in Pain, Postoperative are open now, in 2 countries. Recruiting first, the newest first:
University of Oklahoma · Sites in United States
Ages 18–110
Beijing Tide Pharmaceutical Co., Ltd · Sites in China
Ages 18–70
By country, each count listing its studies:
Meloxicam: first FDA approval 2000 (MOBIC), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 35 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 194 is above the median of 75 across 4,825 interventional studies indexed under Pain, Postoperative.
Median enrollment 112 across the 24 interventional studies. Of the 20 that completed or were terminated, 19 (95%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 24 have an industry lead sponsor. The 4 most frequent:
Baudax Bio is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Baudax Bio has 9 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 24 studies testing meloxicam in Pain, Postoperative, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
Drug: N1539
IV Placebo every 24 hours
Drug: Placebo
Once Daily
Also known as: Intravenous meloxicam
Once Daily
Also known as: Intravenous placebo
Opioid Use Hour 0-24
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
Time frame: Up to 24 Hours
| Milestone | N1539 30 mg | IV Placebo |
|---|---|---|
| Started | 98 | 96 |
| Treated | 93 | 88 |
| Completed | 93 | 88 |
| Not completed | 5 | 8 |
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
| mg morphine equivalent | N1539 30 mg | IV Placebo |
|---|---|---|
| Opioid Use Hour 0-24 | 18.94 ± 1.320 | 27.73 ± 1.371 |
Collected over Through 30 days post dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N1539 30 mg | 0/93 (0%) | 3/93 (3.2%) | 65/93 (69.9%) |
| IV Placebo | 0/88 (0%) | 9/88 (10.2%) | 81/88 (92%) |
| Event | N1539 30 mg | IV Placebo |
|---|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/93 | 2/88 |
| Atrial fibrillationCardiac disorders | 0/93 | 1/88 |
| Cardiac failure congestiveCardiac disorders | 0/93 | 1/88 |
| Oesophageal stenosisGastrointestinal disorders | 0/93 | 1/88 |
| CellulitisInfections and infestations | 0/93 | 1/88 |
| HyponatraemiaMetabolism and nutrition disorders | 0/93 | 1/88 |
| Transient ischaemic attackNervous system disorders | 0/93 | 1/88 |
| Acute kidney injuryRenal and urinary disorders | 0/93 | 1/88 |
| Deep vein thrombosisVascular disorders | 0/93 | 1/88 |
| HypertensionVascular disorders | 0/93 | 1/88 |
| Event | N1539 30 mg | IV Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 37/93 | 52/88 |
| VomitingGastrointestinal disorders | 15/93 | 19/88 |
| PruritusSkin and subcutaneous tissue disorders | 14/93 | 10/88 |
| HypotensionCardiac disorders | 13/93 | 13/88 |
| ConstipationGastrointestinal disorders | 10/93 | 11/88 |
| HypertensionVascular disorders | 0/93 | 7/88 |
| PyrexiaInvestigations | 7/93 | 5/88 |
| HypokalemiaInvestigations | 2/93 | 6/88 |
| DizzinessNervous system disorders | 6/93 | 5/88 |
| HeadacheNervous system disorders | 1/93 | 5/88 |
Safety Population - Subjects who received at least 1 study dose
| Age, Continuous(years) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| Mean | 66.9 ± 8.23 | 65.5 ± 8.11 | 66.2 ± 8.18 |
| Sex: Female, Male(Participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| Female | 54 | 51 | 105 |
| Male | 39 | 37 | 76 |
| Ethnicity (NIH/OMB)(Participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 9 | 18 |
| Not Hispanic or Latino | 84 | 79 | 163 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 17 | 35 |
| White | 74 | 70 | 144 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| United States | 93 | 88 | 181 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Feb 2018 to primary completion in May 2019, 15 months.
Results were first posted in May 2023, 4 years after primary completion.
Of 43 industry-sponsored phase 3 interventional studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's 15 months is above that.
Counting every sponsor, half of 166 studies reached it within 17 months; a quarter within 8 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Meloxicam
Baudax Bio