CompletedNCT02675907Updated Nov 17, 2017Results posted

Evaluation of N1539 Following Bunionectomy Surgery

A Phase 3 interventional study of N1539 and Intravenous Placebo in Pain, Post-operative, sponsored by Baudax Bio. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Baudax Bio · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 201
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.

Conditions studied

Pain, Post-operative

Browse trials for

Pain, Postoperative 5,093

Keywords

Bunion
Bunionectomy
Pain
Analgesia
N1539
Phase 3

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 201 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Baudax Bio is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Voluntarily provide written informed consent.
Male or female between 18 and 75 years of age, inclusive.
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
Be American Society of Anesthesiology (ASA) physical class 1 or 2.
Female subject are eligible only if all the following apply:
- Not pregnant;
- Not lactating;
- Not planning to become pregnant during the study;
- Commit to the use of an acceptable form of birth control for the duration of the study.
Have a body mass index ≤35 kg/m2
Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.

Exclusion criteria

Exclusion Criteria:

Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
Have a clinically significant abnormal clinical laboratory test value.
Have history of or positive test results for HIV, or hepatitis B or C.
Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months
Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
Have a known bleeding disorder or be taking agents affecting coagulation
Have another painful physical condition that may confound the assessments of post operative pain.
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) within the past 5 years or a history of prescription/illicit drug abuse.
Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with N1539.
Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy 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.
Have utilized corticosteroids, either systemically or by intra-articular injection, within 6 weeks prior to the surgical procedure.
Have received any investigational product within 30 days before dosing with study medication.
Be receiving warfarin, 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®) within 7 days prior to surgery
Have previously received N1539 in clinical trials, or had major surgery in the last 3 months that would interfere with study outcomes or increase the risk of study participation.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 201 participants (actual)

Study arms

Experimental
N1539 30mg
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
Drug: N1539
Placebo comparator
IV Placebo
IV Placebo every 24 hours for up to 3 doses.
Drug: Intravenous Placebo

Interventions

DrugN1539
Also known as: Intravenous meloxicam
DrugIntravenous Placebo

What researchers measure

Primary outcomes

Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
Time frame: 48 Hours

Secondary outcomes

Summed Pain Intensity Difference (SPID) at Other Intervals
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
Time frame: 48 Hours
Time to First Dose of Rescue Analgesia
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Time frame: 48 Hours
Number of Subjects Utilizing Rescue Analgesia
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Time frame: 48 Hours
Number of Doses of Rescue Analgesia Utilized Per Subject
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Time frame: 48 Hours
Time to Perceptible Pain Relief (TTPPR)
Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).
Time frame: 12 Hours
Time to Meaningful Pain Relief (TTMPR)
Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).
Time frame: 12 Hours
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 \* SPID6 / (BaselinePI \* 6 \* 60), and SPID6 \< 0 as an indication for improvement.
Time frame: 6 Hours
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 \* SPID24 / (BaselinePI \* 24 \* 60), and SPID24 \< 0 as an indication for improvement.
Time frame: 24 Hours
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 \* SPID6 / (BaselinePI \* 6 \* 60), and SPID6 \< 0 as an indication for improvement.
Time frame: 6 Hours
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 \* SPID24 / (BaselinePI \* 24 \* 60), and SPID24 \< 0 as an indication for improvement.
Time frame: 24 Hours
Patient Global Assessment (PGA) of Pain Control at Hour 24
PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
Time frame: 24 Hours
Patient Global Assessment (PGA) of Pain Control at Hour 48
PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
Time frame: 48 Hours

Results

Posted Sep 29, 2017

Participant flow

Treatment Phase (48 Hours Post-Dose 1)

Participant flow — Treatment Phase (48 Hours Post-Dose 1)
Milestone	N1539 30 mg	IV Placebo
Started	100	101
Completed	95	96
Not completed	5	5
Withdrew: Lack of efficacy	4	4
Withdrew: Withdrawal by subject	1	1

Study Overall

Participant flow — Study Overall
Milestone	N1539 30 mg	IV Placebo
Started	100	101
Completed	97	97
Not completed	3	4
Withdrew: Lack of efficacy	1	0
Withdrew: Withdrawal by subject	2	2
Withdrew: Lost to follow-up	0	2

Outcome measures

PrimarySummed Pain Intensity Difference Over the First 48 Hours (SPID48)

Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.

Time frame:: 48 Hours
Reported as:: Least squares mean · units on a scale

Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
units on a scale	N1539 30 mg	IV Placebo
Summed Pain Intensity Difference Over the First 48 Hours (SPID48)	-6956.0 ± 521.69	-4829.3 ± 519.56

Statistical analysis

N1539 30 mg vs IV Placebo · t-test, 2 sided · p = 0.0034

SecondarySummed Pain Intensity Difference (SPID) at Other Intervals

Time frame:: 48 Hours
Reported as:: Least squares mean · units on a scale

Summed Pain Intensity Difference (SPID) at Other Intervals
units on a scale	N1539 30 mg	IV Placebo
SPID6 (Hour 0-6)	-510.78 ± 66.22	-288.33 ± 65.95
SPID12 (Hour 0-12)	-957.83 ± 123.30	-480.15 ± 122.80
SPID24 (Hour 0-24)	-2071.0 ± 247.01	-1167.9 ± 246.00
SPID12-48 (Hour 12-48)	-5998.2 ± 439.21	-4349.1 ± 437.42
SPID24-48 (Hour 24-48)	-4885.1 ± 313.60	-3661.4 ± 312.32

Statistical analysis

N1539 30 mg vs IV Placebo · t-test, 2 sided · p = <0.05 (Row 1 (SPID6))
N1539 30 mg vs IV Placebo · t-test, 2 sided · p = <0.01 (Row 2 (SPID12))
N1539 30 mg vs IV Placebo · t-test, 2 sided · p = <0.01 (Row 3 (SPID24))
N1539 30 mg vs IV Placebo · t-test, 2 sided · p = <0.01 (Row 4 (SPID12-48))
N1539 30 mg vs IV Placebo · t-test, 2 sided · p = <0.01 (Row 5 (SPID24-48))

SecondaryTime to First Dose of Rescue Analgesia

Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.

Time frame:: 48 Hours
Reported as:: Median · hours

Time to First Dose of Rescue Analgesia
hours	N1539 30 mg	IV Placebo
Time to First Dose of Rescue Analgesia	1.99 (1.53 to 4.12)	2.09 (1.15 to 3.31)

Statistical analysis

N1539 30 mg vs IV Placebo · Log Rank · p = 0.0076

SecondaryNumber of Subjects Utilizing Rescue Analgesia

Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.

Time frame:: 48 Hours
Reported as:: Count of participants · Participants

Number of Subjects Utilizing Rescue Analgesia
Participants	N1539 30 mg	IV Placebo
Hour 0-24	83	99
Hour 24-48	48	71
Hour 0-48	83	99

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = <0.001 (Row 1 (Hour 0-24))
N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = <0.01 (Row 2 (Hour 24-48))
N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = <0.01 (Row 3 (Hour 0-48))

SecondaryNumber of Doses of Rescue Analgesia Utilized Per Subject

Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.

Time frame:: 48 Hours
Reported as:: Least squares mean · doses of rescue analgesia

Number of Doses of Rescue Analgesia Utilized Per Subject
doses of rescue analgesia	N1539 30 mg	IV Placebo
Hour 0-24	3.97 ± 0.26	5.06 ± 0.26
Hour 24-48	1.63 ± 0.25	2.51 ± 0.25
Hour 0-48	5.45 ± 0.46	7.49 ± 0.46

Statistical analysis

N1539 30 mg vs IV Placebo · ANCOVA · p = <0.05 (Row 1 (Hour 0-24))P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site
N1539 30 mg vs IV Placebo · ANCOVA · p = <0.05 (Row 2 (Hour 24-48))P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site
N1539 30 mg vs IV Placebo · ANCOVA · p = <0.05 (Row 3 (Hour 0-48))P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site

SecondaryTime to Perceptible Pain Relief (TTPPR)

Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).

Time frame:: 12 Hours
Reported as:: Median · hours

Time to Perceptible Pain Relief (TTPPR)
hours	N1539 30 mg	IV Placebo
Time to Perceptible Pain Relief (TTPPR)	0.52 (0.35 to 0.74)	1.59 (0.48 to 2.00)

Statistical analysis

N1539 30 mg vs IV Placebo · Log Rank · p = 0.1228

SecondaryTime to Meaningful Pain Relief (TTMPR)

Time frame:: 12 Hours
Reported as:: Median · hours

Time to Meaningful Pain Relief (TTMPR)
hours	N1539 30 mg	IV Placebo
Time to Meaningful Pain Relief (TTMPR)	2.16 (1.00 to 12.01)	3.19 (2.39 to 4.82)

Statistical analysis

N1539 30 mg vs IV Placebo · Log Rank · p = 0.1048

SecondarySubjects With ≥ 30% Improvement in Pain From Baseline to Hour 6

Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 \* SPID6 / (BaselinePI \* 6 \* 60), and SPID6 \< 0 as an indication for improvement.

Time frame:: 6 Hours
Reported as:: Count of participants · Participants

Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6
Participants	N1539 30 mg	IV Placebo
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6	32	20

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = 0.0451

SecondarySubjects With ≥ 30% Improvement in Pain From Baseline to Hour 24

Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 \* SPID24 / (BaselinePI \* 24 \* 60), and SPID24 \< 0 as an indication for improvement.

Time frame:: 24 Hours
Reported as:: Count of participants · Participants

Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24
Participants	N1539 30 mg	IV Placebo
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24	37	21

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = 0.0107

SecondarySubjects With ≥ 50% Improvement in Pain From Baseline to Hour 6

Time frame:: 6 Hours
Reported as:: Count of participants · Participants

Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6
Participants	N1539 30 mg	IV Placebo
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6	16	8

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = 0.0781

SecondarySubjects With ≥ 50% Improvement in Pain From Baseline to Hour 24

Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 \* SPID24 / (BaselinePI \* 24 \* 60), and SPID24 \< 0 as an indication for improvement.

Time frame:: 24 Hours
Reported as:: Count of participants · Participants

Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24
Participants	N1539 30 mg	IV Placebo
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24	13	5

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = 0.0430

SecondaryPatient Global Assessment (PGA) of Pain Control at Hour 24

PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.

Time frame:: 24 Hours
Reported as:: Count of participants · Participants

Patient Global Assessment (PGA) of Pain Control at Hour 24
Participants	N1539 30 mg	IV Placebo
0 - Poor	17	29
1 - Fair	23	26
2 - Good	28	26
3 - Very Good	17	13
4 - Excellent	10	3

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = 0.1070P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site

SecondaryPatient Global Assessment (PGA) of Pain Control at Hour 48

Time frame:: 48 Hours
Reported as:: Count of participants · Participants

Patient Global Assessment (PGA) of Pain Control at Hour 48
Participants	N1539 30 mg	IV Placebo
0 - Poor	7	15
1 - Fair	8	18
2 - Good	26	25
3 - Very Good	30	30
4 - Excellent	24	8

Statistical analysis

N1539 30 mg vs IV Placebo · Cochran-Mantel-Haenszel · p = 0.0046P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site

Adverse events

Collected over AEs collected from time of first dose through last followup (30 days). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
N1539 30 mg	0/100 (0%)	0/100 (0%)	44/100 (44%)
IV Placebo	1/101 (1%)	2/101 (2%)	54/101 (53.5%)

Most frequent serious events

Most frequent serious events
Event	N1539 30 mg	IV Placebo
Sudden deathGeneral disorders	0/100	1/101
FractureInjury, poisoning and procedural complications	0/100	1/101

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	N1539 30 mg	IV Placebo
NauseaGastrointestinal disorders	20/100	26/101
HeadacheNervous system disorders	8/100	12/101
VomitingGastrointestinal disorders	3/100	9/101
PruritusSkin and subcutaneous tissue disorders	8/100	3/101
Decreased appetiteMetabolism and nutrition disorders	2/100	7/101
ConstipationGastrointestinal disorders	4/100	5/101
DizzinessNervous system disorders	3/100	4/101
SomnolenceNervous system disorders	3/100	2/101
FlushingVascular disorders	3/100	1/101
Alanine aminotransferase increasedInvestigations	0/100	3/101

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	N1539 30 mg	IV Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	92	92	184
>=65 years	8	9	17

Age, Continuous
Age, Continuous(years)	N1539 30 mg	IV Placebo	Total
Mean	46.7 ± 12.79	48.4 ± 12.17	47.6 ± 12.48

Sex: Female, Male
Sex: Female, Male(Participants)	N1539 30 mg	IV Placebo	Total
Female	84	87	171
Male	16	14	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	N1539 30 mg	IV Placebo	Total
Hispanic or Latino	28	36	64
Not Hispanic or Latino	72	65	137
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	N1539 30 mg	IV Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	2	3	5
Native Hawaiian or Other Pacific Islander	2	2	4
Black or African American	32	26	58
White	61	68	129
More than one race	3	2	5
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	N1539 30 mg	IV Placebo	Total
United States	100	101	201

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	N1539 30 mg	IV Placebo	Total
Mean	26.9 ± 4.80	28.3 ± 4.02	27.6 ± 4.46

Time from End of Surgery to First Dose
Time from End of Surgery to First Dose(hours)	N1539 30 mg	IV Placebo	Total
Mean	0.514 ± 0.2397	0.485 ± 0.2001	0.500 ± 0.2206

1 further baseline measures are reported on the registry.

Study locations

4 sites

Trovare Clinical Research
Bakersfield, California, United States
Lotus Clinical Research
Pasadena, California, United States
Chesapeake Research Group
Pasadena, Maryland, United States
Endeavor Clinical Trials
San Antonio, Texas, United States

References and documents

Publications

Viscusi 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 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02675907
Lead sponsor: Baudax Bio
Responsible party: Sponsor
First posted: Feb 5, 2016
Start date: Jan 2016
Primary completion: Jul 2016
Completion: Jul 2016
Results posted: Sep 29, 2017
Last update: Nov 17, 2017

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Evaluation of N1539 Following Bunionectomy Surgery

Study summary

Conditions studied

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Keywords

In context

Pain, Postoperative

Lead sponsor

Who can participate

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✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Oversight

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Follow this study

Discussion

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