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| Name | Class |
|---|---|
| Nevakar Injectables, Inc. | INDUSTRY |
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A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
Up to 80 subjects will be randomized (32 in each active treatment group, 16 placebo).
To evaluate the efficacy of combination pregabalin (PGB) and acetaminophen (APAP) administered vs. placebo for pain control in subjects undergoing bunionectomy.
The placebo will be the saline solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGB and APAP (Group A) | Experimental | Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery. |
|
| APAP (Group B) | Experimental | Group B receives placebo 2 prior to surgery and APAP post-surgery. |
|
| Placebo (Group C). | Experimental | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties. |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity (SPI) Between Group A and Group C | Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, was used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: Sum (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and placebo (Group C) from Hour 0 to Hour 48 (SPI0-48) | 0 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity (SPI) Compared Between Group A and Group B | Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) -was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and APAP alone (Group B) from Hour 0 to Hour 48 (SPI0-48) |
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Inclusion Criteria:
Exclusion Criteria:
Have a medical condition or history that in the Investigator's opinion could adversely impact the subject's participation or safety or the conduct of the study, or interfere with the pain assessments, including the following:
Serious breathing difficulties or respiratory risk factors (including use of opioid pain medicines and other drugs that depress the central nervous system), and conditions such as chronic obstructive pulmonary disease that reduce lung function.
Hypertension (uncontrolled), cardiovascular disease, or history of cerebrovascular events. Hypertension must be controlled without known end organ damage.
Concurrent painful conditions that may require analgesic treatment during the study period.
History of significantly reduced hepatic or renal function, angle closure glaucoma, or convulsive disorder.
Recent history of urinary retention.
Opioid tolerant, i.e., the subject is currently taking or has taken a chronic opioid at a dose greater than or equal to 20 mg morphine milligram equivalents (MME) per day (more than 30 consecutive days of daily use) for pain in the 2 months prior to surgery.
Active cutaneous disease, or other disease, at the surgical site.
Peripheral vascular disease, sickle cell disease, vascular grafts, or vasospastic disorders.
Known bleeding disorder or is taking agents affecting coagulation preoperatively.
Deep venous thrombosis (DVT) prophylaxis of the surgeon's choice is permitted postoperatively.
Diabetes mellitus (uncontrolled). Diabetes mellitus must be controlled without known end organ damage.
History of malignancy in the past 2 years with the exception of squamous cell carcinoma or basal cell carcinoma.
Prior bunionectomy on the index foot or other foot surgery on the index foot that could impact the surgery or data collection endpoints.
Use of disallowed medications including the following:
Use of warfarin is allowed, at the investigator's discretion, for DVT prophylaxis after the surgery.
Significant history of allergic reactions or known intolerance to pregabalin or any gabapentinoid, to APAP, to any rescue medication used in the study, or any medication used in the surgical and anesthetic protocol.
Female subjects (biological females only) who are pregnant or lactating, who plan to get pregnant, or who have a positive serum pregnancy test at Screening or a positive urine pregnancy test at either Day -1 or Day 1 prior to surgery.
Participated in another clinical trial within 30 days, or previously participated in a clinical study with a similar investigational product.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Resarch,LLC | Pasadena | California | 91105 | United States | ||
| Lotus HD Research |
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Subjects underwent a Screening Visit (Day -42 to Day -2) and were required to sign an informed consent form (ICF) before undertaking any study-specific procedures or assessments. Pre-operative assessments were conducted within 24 hours prior to surgery (on either Day -1 or Day 1 prior to surgery.
Participants were recruited from 28 July 2020 till 26 Oct 2020 across the sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | PGB and APAP (Group A) | Group A receives pregabalin (PGB) plus acetaminophen (APAP) prior to surgery and placebo 1 post-surgery. |
| FG001 | APAP (Group B) | Group B receives placebo 2 prior to surgery and APAP post-surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2020 |
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Parallel Assignment
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Up to 80 subjects will be randomized (32 in each active treatment group, 16 placebo).
Eligible subjects will be randomized on Day 1 in a 2:2:1 ratio to receive either a combination of PGB and APAP administered (Group A), APAP (Group B), or placebo (Group C).
|
| Acetaminophen | Drug | Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. |
|
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| Placebo 1 | Other | Placebo for APAP |
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| Placebo 2 | Other | Placebo for combination |
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| 0 to 48 hours |
| Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale From Hour 0 to Hour 12 (SPI0-12), Hour 12 to Hour 24 (SPI12-24), and Hour 24 to Hour 48 (SPI24-48). | Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals at 0-12, 12-24 and 24-48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time interval (0-12, 12-24 and 24-48 hours). This outcome was compared between a combination of PGB and APAP, APAP alone, and placebo. | 0, 12, 24, 48 hours |
| Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time | Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals from 0 hour till each time point at 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time intervals. | 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours |
| Number of Participants With Treatment-Related Adverse Events (TRAE) | A TRAE is defined as a treatment-emergent adverse event (TEAE) that was classified by the investigator as related to study drug. The number of participants with TRAE were reported | 7 days |
| Percentage of Participants Who Were Opioid Free Over Time | Percentages of participants who did not take opioid (rescue medication) over time. | 12 to 48 hours |
| Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours | The total consumption of opioid rescue analgesia through 24 hours and through 48 hours was reported | 24 hours and 48 hours |
| Total Consumption of Rescue Medication | The total consumption of rescue analgesia was reported. | 7 days |
| Time to First Use of Rescue Medication From Hour 0 | Time to first use of rescue medication from Hour 0 was reported. Hour 0 was defined as the end of surgery (i.e., completion of the last suture). | 7 days |
| Percentage of Participants Who Used Rescue Medication | Percentage of participants who used rescue medication is reported | 7 days |
| Patient Global Assessment of Pain | Patient Global Assessment (PGA) of pain control at 48 hours was reported. Patient global evaluation will be self-reported over 24 hours, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent | 48 hours |
| Maximum Observed Concentration for PGB and APAP | The Plasma Concentration (Cmax) is defined as the maximum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. | Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion |
| Minimum Observed Concentration for PGB and APAP | The Plasma Concentration (Cmin) is defined as the minimum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. | Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion |
| Bellaire |
| Texas |
| 77401 |
| United States |
| FG002 | Placebo (Group C). | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all subjects who received any amount of study drug (APAP + PGB, APAP, or placebo), whether or not they were prematurely withdrawn from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | PGB and APAP (Group A) | Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery. |
| BG001 | APAP (Group B) | Group B receives placebo 2 prior to surgery and APAP post-surgery. |
| BG002 | Placebo (Group C). | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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 (SPI) Between Group A and Group C | Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, was used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: Sum (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and placebo (Group C) from Hour 0 to Hour 48 (SPI0-48) | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | 0 to 48 hours |
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| Secondary | Summed Pain Intensity (SPI) Compared Between Group A and Group B | Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) -was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and APAP alone (Group B) from Hour 0 to Hour 48 (SPI0-48) | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | 0 to 48 hours |
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| Secondary | Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale From Hour 0 to Hour 12 (SPI0-12), Hour 12 to Hour 24 (SPI12-24), and Hour 24 to Hour 48 (SPI24-48). | Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals at 0-12, 12-24 and 24-48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time interval (0-12, 12-24 and 24-48 hours). This outcome was compared between a combination of PGB and APAP, APAP alone, and placebo. | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | 0, 12, 24, 48 hours |
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| Secondary | Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time | Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals from 0 hour till each time point at 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time intervals. | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Mean | Standard Deviation | score on a scale | 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours |
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| Secondary | Number of Participants With Treatment-Related Adverse Events (TRAE) | A TRAE is defined as a treatment-emergent adverse event (TEAE) that was classified by the investigator as related to study drug. The number of participants with TRAE were reported | The Safety Analysis Set included all subjects who received any amount of study drug (APAP + PGB, APAP, or placebo), whether or not they were prematurely withdrawn from the study. The Safety Analysis Set was used for the summaries and listings of all safety assessments. Subjects were analyzed according to treatment received | Posted | Number | participants | 7 days |
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| Secondary | Percentage of Participants Who Were Opioid Free Over Time | Percentages of participants who did not take opioid (rescue medication) over time. | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Number | percentage of participants | 12 to 48 hours |
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| Secondary | Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours | The total consumption of opioid rescue analgesia through 24 hours and through 48 hours was reported | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Mean | Standard Deviation | oral morphine equivalents | 24 hours and 48 hours |
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| Secondary | Total Consumption of Rescue Medication | The total consumption of rescue analgesia was reported. | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Mean | Standard Deviation | oral morphine equivalents | 7 days |
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| Secondary | Time to First Use of Rescue Medication From Hour 0 | Time to first use of rescue medication from Hour 0 was reported. Hour 0 was defined as the end of surgery (i.e., completion of the last suture). | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Median | 90% Confidence Interval | hours | 7 days |
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| Secondary | Percentage of Participants Who Used Rescue Medication | Percentage of participants who used rescue medication is reported | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Number | percentage of participants | 7 days |
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| Secondary | Patient Global Assessment of Pain | Patient Global Assessment (PGA) of pain control at 48 hours was reported. Patient global evaluation will be self-reported over 24 hours, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent | The Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment group to which they were randomized. | Posted | Count of Participants | Participants | 48 hours |
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| Secondary | Maximum Observed Concentration for PGB and APAP | The Plasma Concentration (Cmax) is defined as the maximum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. | The PK Analysis Set included all randomized subjects who received any amount of study drug, had no protocol deviations affecting the pharmacokinetic (PK) variables, and had sufficient data collected to allow evaluation of least one PK parameter (minimum plasma concentration of the drug [Cmin], Cmax, or both). Subjects were analyzed according to treatment received. All PK analyses were performed using the PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/ml) | Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion |
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| Secondary | Minimum Observed Concentration for PGB and APAP | The Plasma Concentration (Cmin) is defined as the minimum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. | The PK Analysis Set included all randomized subjects who received any amount of study drug, had no protocol deviations affecting the PK variables, and had sufficient data collected to allow evaluation of least one PK parameter (minimum plasma concentration of the drug [Cmin], Cmax, or both). Subjects were analyzed according to treatment received. All PK analyses were performed using the PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/ml) | Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion |
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Up to 7 days (± 1 day)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
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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 | PGB and APAP (Group A) | Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery. | 0 | 35 | 0 | 35 | 27 | 35 |
| EG001 | APAP (Group B) | Group B receives placebo 2 prior to surgery and APAP post-surgery | 0 | 35 | 0 | 35 | 15 | 35 |
| EG002 | Placebo (Group C). | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery | 0 | 17 | 0 | 17 | 9 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Application site rash | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Infusion site extravasation | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Injection site extravasation | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Post procedural cellulitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
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| Transaminases abnormal | Investigations | MedDRA Version 23.0 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA Version 23.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Lang, MD | Nevakar, Inc. | (908) 367-7400 | Clinicaltrials@nevakar.com |
| Aug 28, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D011456 | Prostaglandins B |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Group B receives placebo 2 prior to surgery and APAP post-surgery.
|
|
|
Group B receives placebo 2 prior to surgery and APAP post-surgery. |
| OG002 | Placebo (Group C). | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery |
|
|
Group B receives placebo 2 prior to surgery and APAP post-surgery.
| OG002 | Placebo (Group C). | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Participants |
|
|
| Placebo (Group C). |
Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
|
|
| Placebo (Group C). |
Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
|
|