Evaluation of N1539 Following Major Surgery

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ClinicalTrials.gov Identifier: NCT02720692

Recruitment Status : Completed

First Posted : March 28, 2016

Results First Posted : May 25, 2023

Last Update Posted : May 25, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Baudax Bio

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Pain, Post-operative
Interventions	Drug: N1539 Drug: Intravenous Placebo
Enrollment	722

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	N1539 30 mg	IV Placebo
Arm/Group Description	N1539 (Intravenous meloxicam) 30 mg...	IV Placebo every 24 hours for up to...
Arm/Group Description	N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Period Title: Overall Study
Started	539	183
Treated	538	183
Completed Treatment	519	177
Completed	526	180
Not Completed	13	3
Reason Not Completed
Withdrawal by Subject	3	0
Physician Decision	1	0
Lost to Follow-up	8	3
Subject unable to return for visit	1	0

Baseline Characteristics

Arm/Group Title		N1539 30 mg	IV Placebo	Total
Arm/Group Description		N1539 (Intravenous meloxicam) 30 mg...	IV Placebo every 24 hours for up to...	Total of all reporting groups
Arm/Group Description		N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo	Total of all reporting groups
Overall Number of Baseline Participants		538	183	721
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All Treated Subjects (Safety Analysis Set)
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	183 participants	721 participants
	<=18 years	2 0.4%	0 0.0%	2 0.3%
	Between 18 and 65 years	416 77.3%	140 76.5%	556 77.1%
	>=65 years	120 22.3%	43 23.5%	163 22.6%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	538 participants	183 participants	721 participants
		52.9 (13.56)	53.0 (13.77)	53.0 (13.60)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	183 participants	721 participants
	Female	315 58.6%	113 61.7%	428 59.4%
	Male	223 41.4%	70 38.3%	293 40.6%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	183 participants	721 participants
	Hispanic or Latino	76 14.1%	29 15.8%	105 14.6%
	Not Hispanic or Latino	462 85.9%	154 84.2%	616 85.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	183 participants	721 participants
	American Indian or Alaska Native	1 0.2%	0 0.0%	1 0.1%
	Asian	7 1.3%	4 2.2%	11 1.5%
	Native Hawaiian or Other Pacific Islander	2 0.4%	0 0.0%	2 0.3%
	Black or African American	68 12.6%	21 11.5%	89 12.3%
	White	459 85.3%	155 84.7%	614 85.2%
	More than one race	1 0.2%	3 1.6%	4 0.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	538 participants	183 participants	721 participants
United States		502	168	670
Canada		5	3	8
New Zealand		8	2	10
Australia		23	10	33
Advanced Age (>65) with Impaired Renal Function (GFR<90) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	183 participants	721 participants
		88 16.4%	31 16.9%	119 16.5%
Surgery Site/Type Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	183 participants	721 participants
	Orthopedic	273 50.7%	93 50.8%	366 50.8%
	Abdominal/Pelvic	254 47.2%	87 47.5%	341 47.3%
	Spinal	10 1.9%	3 1.6%	13 1.8%
	Other	1 0.2%	0 0.0%	1 0.1%

Outcome Measures

1.Primary Outcome


Title	Number of Subjects With Adverse Events
Description	Number of subjects reporting 1 or more treatment-emergent adverse even...
Description	Number of subjects reporting 1 or more treatment-emergent adverse events
Time Frame	28 Days

Outcome Measure Data

Analysis Population Description

All Treated Subjects (Safety Analysis Set)


Arm/Group Title	N1539 30 mg	IV Placebo
Arm/Group Description:	N1539 (Intravenous meloxicam) 30 mg...	IV Placebo every 24 hours for up to...
Arm/Group Description:	N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Overall Number of Participants Analyzed	538	183
Measure Type: Count of Participants Unit of Measure: Participants
	339 63.0%	119 65.0%

2.Secondary Outcome


Title	Investigator Satisfaction With Surgical Wound Healing
Description	Investigators assessed their satisfaction with the healing of the surg...
Description	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, and a score of 10 was completely satisfied.
Time Frame	Up to 7 days after last study dose

Outcome Measure Data

Analysis Population Description

All Treated Subjects (Safety Analysis Set)


Arm/Group Title	N1539 30 mg	IV Placebo
Arm/Group Description:	N1539 (Intravenous meloxicam) 30 mg...	IV Placebo every 24 hours for up to...
Arm/Group Description:	N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Overall Number of Participants Analyzed	538	183
Mean (Standard Deviation) Unit of Measure: units on a scale
One day after last study dose/Discharge	9.5 (0.88)	9.4 (0.97)
7 Days after last study dose	9.3 (1.18)	9.4 (0.86)

3.Secondary Outcome


Title	Postoperative Opioid Use
Description	Postoperative opioid use was measured throughout the inpatient phase a...
Description	Postoperative opioid use was measured throughout the inpatient phase and converted to the total IV morphine equivalent dose
Time Frame	Up to 7 days

Outcome Measure Data

Analysis Population Description

All Treated Subjects (Safety Analysis Set)


Arm/Group Title	N1539 30 mg	IV Placebo
Arm/Group Description:	N1539 (Intravenous meloxicam) 30 mg...	IV Placebo every 24 hours for up to...
Arm/Group Description:	N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Overall Number of Participants Analyzed	538	183
Mean (Standard Deviation) Unit of Measure: mg (IV Morphine Equivalent Dose)
Day 1 (Hour 0-24)	17.0 (22.10)	21.8 (24.70)
Day 2 (Hour 24-48)	8.6 (19.15)	11.3 (21.82)
Day 3 (Hour 48-72)	4.1 (16.60)	6.2 (21.83)
Day 1-2 (Hour 0-48)	25.3 (36.96)	32.7 (41.44)
Day 1-3 (Hour 0-72)	27.4 (44.67)	35.9 (52.77)
During Treatment	28.8 (57.39)	37.5 (66.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	N1539 30 mg, IV Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	P<0.05 applies to Day 1 (0-24 Hours; p=0.0033), Days 1-2 (0-48 Hours; p=0.0077), and Days 1-3 (0-72 Hours; p=0.0152).
	Method	ANCOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	N1539 30 mg		IV Placebo
Arm/Group Description	N1539 (Intravenous meloxicam) 30 mg...		IV Placebo every 24 hours for up to...
Arm/Group Description	N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539		IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
All-Cause Mortality
	N1539 30 mg		IV Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/538 (0.00%)		0/183 (0.00%)
Serious Adverse Events Serious Adverse Events
	N1539 30 mg		IV Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/538 (2.60%)		10/183 (5.46%)
Blood and lymphatic system disorders
Anaemia ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Cardiac disorders
Coronary artery disease ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Gastrointestinal disorders
Intestinal perforation ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Jejunal stenosis ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Nausea ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Omental infarction ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Small intestinal obstruction ^* 1	2/538 (0.37%)	2	0/183 (0.00%)	0
Hepatobiliary disorders
Hepatocellular injury ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Infections and infestations
Abdominal abscess ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Diverticulitis ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Incision site infection ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Mesenteric abscess ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Pneumonia ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Postoperative abscess ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Septic shock ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Injury, poisoning and procedural complications
Anastomotic ulcer ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Femoral neck fracture ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Incisional hernia ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Post procedural pulmonary embolism ^* 1	3/538 (0.56%)	3	0/183 (0.00%)	0
Postoperative ileus ^* 1	1/538 (0.19%)	1	1/183 (0.55%)	1
Tendon injury ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Investigations
Liver function test abnormal ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Metabolism and nutrition disorders
Hypervolaemia ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
Nervous system disorders
Dizziness ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Renal and urinary disorders
Acute kidney injury ^* 1	2/538 (0.37%)	2	0/183 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Respiratory arrest ^* 1	0/538 (0.00%)	0	1/183 (0.55%)	1
Respiratory distress ^* 1	1/538 (0.19%)	1	0/183 (0.00%)	0
1 Term from vocabulary, MedDRA (18.1) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	N1539 30 mg		IV Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	227/538 (42.19%)		85/183 (46.45%)
Blood and lymphatic system disorders
Anaemia ^* 1	18/538 (3.35%)	18	4/183 (2.19%)	4
Gastrointestinal disorders
Constipation ^* 1	51/538 (9.48%)	51	17/183 (9.29%)	17
Vomiting ^* 1	27/538 (5.02%)	30	14/183 (7.65%)	15
Nausea ^* 1	123/538 (22.86%)	129	50/183 (27.32%)	57
Investigations
Alanine aminotransferase increased ^* 1	11/538 (2.04%)	11	7/183 (3.83%)	7
Gamma-glutamyltransferase increased ^* 1	21/538 (3.90%)	21	5/183 (2.73%)	5
Nervous system disorders
Dizziness ^* 1	15/538 (2.79%)	15	7/183 (3.83%)	8
Headache ^* 1	20/538 (3.72%)	21	12/183 (6.56%)	13
Psychiatric disorders
Insomnia ^* 1	9/538 (1.67%)	9	6/183 (3.28%)	6
Skin and subcutaneous tissue disorders
Pruritus ^* 1	21/538 (3.90%)	21	10/183 (5.46%)	10
Vascular disorders
Hypotension ^* 1	9/538 (1.67%)	9	6/183 (3.28%)	6
1 Term from vocabulary, MedDRA (18.1) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Development
Organization:	Baudax Bio Inc.
Phone:	484-395-2440
EMail:	info@baudaxbio.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Bergese 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. Erratum In: Clin Pharmacol Drug Dev. 2020 Aug;9(6):774.

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.

Layout table for additonal information

Responsible Party:	Baudax Bio
ClinicalTrials.gov Identifier:	NCT02720692
Other Study ID Numbers:	REC-15-017
First Submitted:	March 22, 2016
First Posted:	March 28, 2016
Results First Submitted:	April 28, 2023
Results First Posted:	May 25, 2023
Last Update Posted:	May 25, 2023

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