Trial Outcomes & Findings for Evaluation of N1539 Following Major Surgery (NCT NCT02720692)

NCT ID: NCT02720692

Last Updated: 2023-06-22

Results Overview

Number of subjects reporting 1 or more treatment-emergent adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 722 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2023-06-22

Participant Flow

Participant milestones

Measure	N1539 30 mg N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Overall Study STARTED	539	183
Overall Study Treated	538	183
Overall Study Completed Treatment	519	177
Overall Study COMPLETED	526	180
Overall Study NOT COMPLETED	13	3

Reasons for withdrawal

Measure	N1539 30 mg N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Overall Study Withdrawal by Subject	3	0
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	8	3
Overall Study Subject unable to return for visit	1	0

Baseline Characteristics

Evaluation of N1539 Following Major Surgery

Baseline characteristics by cohort

Measure	N1539 30 mg n=538 Participants N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo n=183 Participants IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo	Total n=721 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	416 Participants n=5 Participants	140 Participants n=7 Participants	556 Participants n=5 Participants
Age, Categorical >=65 years	120 Participants n=5 Participants	43 Participants n=7 Participants	163 Participants n=5 Participants
Age, Continuous	52.9 years STANDARD_DEVIATION 13.56 • n=5 Participants	53.0 years STANDARD_DEVIATION 13.77 • n=7 Participants	53.0 years STANDARD_DEVIATION 13.60 • n=5 Participants
Sex: Female, Male Female	315 Participants n=5 Participants	113 Participants n=7 Participants	428 Participants n=5 Participants
Sex: Female, Male Male	223 Participants n=5 Participants	70 Participants n=7 Participants	293 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	76 Participants n=5 Participants	29 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	462 Participants n=5 Participants	154 Participants n=7 Participants	616 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	68 Participants n=5 Participants	21 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) White	459 Participants n=5 Participants	155 Participants n=7 Participants	614 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	502 participants n=5 Participants	168 participants n=7 Participants	670 participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment New Zealand	8 participants n=5 Participants	2 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Australia	23 participants n=5 Participants	10 participants n=7 Participants	33 participants n=5 Participants
Advanced Age (>65) with Impaired Renal Function (GFR<90)	88 Participants n=5 Participants	31 Participants n=7 Participants	119 Participants n=5 Participants
Surgery Site/Type Orthopedic	273 Participants n=5 Participants	93 Participants n=7 Participants	366 Participants n=5 Participants
Surgery Site/Type Abdominal/Pelvic	254 Participants n=5 Participants	87 Participants n=7 Participants	341 Participants n=5 Participants
Surgery Site/Type Spinal	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Surgery Site/Type Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: All Treated Subjects (Safety Analysis Set)

Number of subjects reporting 1 or more treatment-emergent adverse events

Outcome measures

Measure	N1539 30 mg n=538 Participants N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo n=183 Participants IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Number of Subjects With Adverse Events	339 Participants	119 Participants

SECONDARY outcome

Timeframe: Up to 7 days after last study dose

Population: All Treated Subjects (Safety Analysis Set)

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 (worse outcome), and a score of 10 was completely satisfied (better outcome).

Outcome measures

Measure	N1539 30 mg n=538 Participants N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo n=183 Participants IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Investigator Satisfaction With Surgical Wound Healing One day after last study dose/Discharge	9.5 score on a scale Standard Deviation 0.88	9.4 score on a scale Standard Deviation 0.97
Investigator Satisfaction With Surgical Wound Healing 7 Days after last study dose	9.3 score on a scale Standard Deviation 1.18	9.4 score on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: Up to 7 days

Population: All Treated Subjects (Safety Analysis Set)

Postoperative opioid use was measured throughout the inpatient phase and converted to the total IV morphine equivalent dose

Outcome measures

Measure	N1539 30 mg n=538 Participants N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo n=183 Participants IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Postoperative Opioid Use Day 1 (Hour 0-24)	17.0 mg (IV Morphine Equivalent Dose) Standard Deviation 22.10	21.8 mg (IV Morphine Equivalent Dose) Standard Deviation 24.70
Postoperative Opioid Use Day 2 (Hour 24-48)	8.6 mg (IV Morphine Equivalent Dose) Standard Deviation 19.15	11.3 mg (IV Morphine Equivalent Dose) Standard Deviation 21.82
Postoperative Opioid Use Day 3 (Hour 48-72)	4.1 mg (IV Morphine Equivalent Dose) Standard Deviation 16.60	6.2 mg (IV Morphine Equivalent Dose) Standard Deviation 21.83
Postoperative Opioid Use Day 1-2 (Hour 0-48)	25.3 mg (IV Morphine Equivalent Dose) Standard Deviation 36.96	32.7 mg (IV Morphine Equivalent Dose) Standard Deviation 41.44
Postoperative Opioid Use Day 1-3 (Hour 0-72)	27.4 mg (IV Morphine Equivalent Dose) Standard Deviation 44.67	35.9 mg (IV Morphine Equivalent Dose) Standard Deviation 52.77
Postoperative Opioid Use During Treatment	28.8 mg (IV Morphine Equivalent Dose) Standard Deviation 57.39	37.5 mg (IV Morphine Equivalent Dose) Standard Deviation 66.06

Adverse Events

N1539 30 mg

Serious events: 14 serious events

Other events: 227 other events

Deaths: 0 deaths

IV Placebo

Serious events: 10 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Measure	N1539 30 mg n=538 participants at risk N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo n=183 participants at risk IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Blood and lymphatic system disorders Anaemia	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Cardiac disorders Coronary artery disease	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Intestinal perforation	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Jejunal stenosis	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Nausea	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Omental infarction	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Small intestinal obstruction	0.37% 2/538 • Number of events 2 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Abdominal abscess	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Diverticulitis	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Incision site infection	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Mesenteric abscess	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Pneumonia	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Postoperative abscess	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Infections and infestations Septic shock	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Injury, poisoning and procedural complications Femoral neck fracture	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Injury, poisoning and procedural complications Post procedural pulmonary embolism	0.56% 3/538 • Number of events 3 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Injury, poisoning and procedural complications Postoperative ileus	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Injury, poisoning and procedural complications Tendon injury	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Investigations Liver function test abnormal	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Metabolism and nutrition disorders Hypervolaemia	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Nervous system disorders Dizziness	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Renal and urinary disorders Acute kidney injury	0.37% 2/538 • Number of events 2 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/538 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.55% 1/183 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.19% 1/538 • Number of events 1 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	0.00% 0/183 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.

Other adverse events

Measure	N1539 30 mg n=538 participants at risk N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 7 doses. N1539	IV Placebo n=183 participants at risk IV Placebo every 24 hours for up to 7 doses. Intravenous Placebo
Blood and lymphatic system disorders Anaemia	3.3% 18/538 • Number of events 18 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	2.2% 4/183 • Number of events 4 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Constipation	9.5% 51/538 • Number of events 51 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	9.3% 17/183 • Number of events 17 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Vomiting	5.0% 27/538 • Number of events 30 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	7.7% 14/183 • Number of events 15 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Gastrointestinal disorders Nausea	22.9% 123/538 • Number of events 129 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	27.3% 50/183 • Number of events 57 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Investigations Alanine aminotransferase increased	2.0% 11/538 • Number of events 11 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	3.8% 7/183 • Number of events 7 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Investigations Gamma-glutamyltransferase increased	3.9% 21/538 • Number of events 21 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	2.7% 5/183 • Number of events 5 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Nervous system disorders Dizziness	2.8% 15/538 • Number of events 15 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	3.8% 7/183 • Number of events 8 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Nervous system disorders Headache	3.7% 20/538 • Number of events 21 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	6.6% 12/183 • Number of events 13 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Psychiatric disorders Insomnia	1.7% 9/538 • Number of events 9 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	3.3% 6/183 • Number of events 6 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Skin and subcutaneous tissue disorders Pruritus	3.9% 21/538 • Number of events 21 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	5.5% 10/183 • Number of events 10 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.
Vascular disorders Hypotension	1.7% 9/538 • Number of events 9 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.	3.3% 6/183 • Number of events 6 • AE data were collected from the time of first study dose, through the last study contact, 28 days following the last study dose.

Additional Information

Development

Baudax Bio Inc.

Phone: 484-395-2440

Email: info@baudaxbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER