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The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N1539 30mg | Experimental | N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses. |
|
| IV Placebo | Placebo Comparator | IV Placebo every 24 hours for up to 3 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N1539 | Drug |
|
| |
| Intravenous Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference Over the First 24 Hours (SPID24) | 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. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Voluntarily provide written informed consent.
Male or female between 18 and 75 years of age, inclusive.
Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.
Be American Society of Anesthesiology (ASA) physical class 1 or 2.
Female subject are eligible only if all the following apply:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | United States | |||
| HD Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30737315 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | N1539 30 mg | N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses. N1539 |
| FG001 | IV Placebo | IV Placebo every 24 hours for up to 3 doses. Intravenous Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase (48 Hours Post-Dose 1) |
|
| |||||||||||||||||||||
| Study Overall (28 Day Follow-Up) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N1539 30 mg | N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses. N1539 |
| BG001 | IV Placebo | IV Placebo every 24 hours for up to 3 doses. Intravenous Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summed Pain Intensity Difference Over the First 24 Hours (SPID24) | 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. | Intent-to-Treat (ITT) population | Posted | Least Squares Mean | Standard Error | units on a scale | 24 Hours |
|
AEs collected from time of first dose through last followup (30 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N1539 30 mg | N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses. N1539 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative wound infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall Mack | Recro Pharma | 484-35-2470 | 2406 | rmack@recropharma.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| Drug |
|
| 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. | 48 Hours |
| Number of Subjects Utilizing Rescue Analgesia | Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 48 Hours |
| Bellaire |
| Texas |
| United States |
| Research Concepts | Bellaire | Texas | United States |
| Endeavor Clinical Trials | San Antonio | Texas | United States |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Time from End of Surgery to First Dose | Mean | Standard Deviation | hours |
|
| Baseline Pain Intensity | Pain Intensity was assessed using the 11-point Numeric Pain Rating Scale (NPRS; 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). The baseline assessment was the NPRS score collected prior to the first study dose. | Mean | Standard Deviation | units on a scale |
|
N1539 (Intravenous meloxicam) 30 mg every 24 hours for up to 3 doses. N1539 |
| OG001 | IV Placebo | IV Placebo every 24 hours for up to 3 doses. Intravenous Placebo |
|
|
|
| Secondary | 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. | ITT Population | Posted | Least Squares Mean | Standard Error | units on a scale | 48 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Median | 95% Confidence Interval | hours | 48 Hours |
|
|
|
|
| Secondary | Number of Subjects Utilizing Rescue Analgesia | Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. | ITT Population | Posted | Count of Participants | Participants | 48 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Least Squares Mean | Standard Error | doses of rescue analgesia | 48 Hours |
|
|
|
|
| Secondary | 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). | ITT Population | Posted | Median | 95% Confidence Interval | hours | 12 Hours |
|
|
|
|
| Secondary | 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). | ITT Population | Posted | Median | 95% Confidence Interval | hours | 12 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 6 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 24 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 6 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 24 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 24 Hours |
|
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 48 Hours |
|
|
|
|
| 0 |
| 110 |
| 1 |
| 110 |
| 50 |
| 110 |
| EG001 | IV Placebo | IV Placebo every 24 hours for up to 3 doses. Intravenous Placebo | 0 | 109 | 3 | 109 | 74 | 109 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Post procedural pulmonary embolism | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chills | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| SPID48 (Hour 0-48) |
|
| SPID24-48 (Hour 24-48) |
|
Row 2 (SPID12) |
| Superiority |
| t-test, 2 sided | 0.0040 | Row 3 (SPID48) | Superiority |
| t-test, 2 sided | 0.0028 | Row 4 (SPID24-48) | Superiority |
| Hour 0-48 |
|
Row 2 (Hour 24-48) |
| Superiority |
| Cochran-Mantel-Haenszel | 0.4994 | Row 3 (Hour 0-48) | Superiority |
| Hour 0-48 |
|
P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site |
| 0.0009 |
Row 2 (Hour 24-48) |
| Superiority |
| ANCOVA | P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site | 0.0027 | Row 3 (Hour 0-48) | Superiority |
| 2 - Good |
|
| 3 - Very Good |
|
| 4 - Excellent |
|
| Not Done |
|
| 2 - Good |
|
| 3 - Very Good |
|
| 4 - Excellent |
|
| Not Done |
|