Postoperative PainPhase 2NCT04495283
A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
A Phase 2 study testing Pregabalin and Acetaminophen in people with Postoperative Pain, run by Nevakar, Inc. at 2 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin and Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2020to 12 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide informed consent by signing the informed consent form (ICF) approved by the Institutional Review Board (IRB);
- Be male or female aged 18-65 years;
- Be scheduled to undergo unilateral first metatarsal bunionectomy;
- Be in good health and capable of undergoing a bunionectomy under anesthesia as described in the study surgical and anesthetic protocol;
- Weigh between 50 and 100 kg (body mass index [BMI] <32 kg/m2);
- Have no additional planned surgeries other than bunionectomy during the course of the study;
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- Have negative urine drug screen for drugs indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator) and no detectable results on the alcohol test (breath or saliva) indicative of alcohol abuse at screening, and/or prior to surgery (may be repeated if the Investigator suspects a false-positive result). Note: For those subjects who test positive for tetrahydrocannabinol (THC), if they are willing to abstain from use or consumption of THC-containing products from screening through end of the subject's participation in the study, they may be allowed to participate in the study.
- Biological female subjects must be non-lactating, sterile (bilateral tubal ligation, bilateral salpingectomy, or hysterectomy), post-menopausal for at least 2 years, have a partner that is sterile, be abstinent, use a highly effective double- contraception method (hormonal protection is insufficient), or use an FDA-approved contraceptive for greater than 2 months prior to the screening visit and commit to an acceptable form of birth control for the duration of the study and for 30 days after completion of the study;
- Be willing and able to complete the study procedures and pain scales and communicate meaningfully in English with study personnel.
Who cannot join
- 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.
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- 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:
- Pain medication (opioids, NSAIDs, cyclooxygenase (COX)-2 inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin, or cannabinoids) within 2 days prior to Day 1.
- Central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors (SNRIs), or selective serotonin reuptake inhibitors (SSRIs) for pain within seven days prior to Day 1. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days prior to Day 1 and is planned to remain stable throughout the study. The use of lorazepam and other sleep medications, except those containing analgesic properties, is permitted.
- Use of parenteral or oral corticosteroid(s) within 14 days prior to Day 1.
- Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days, or which is not expected to remain stable throughout the study.
- Digoxin, warfarin (see exception below), lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics except beta-blockers, and use of anticonvulsants except benzodiazepines within 7 days prior to Day 1 and throughout the study.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lotus HD Research
Bellaire, Texas, 77401
Lotus Clinical Resarch,LLC
Pasadena, California, 91105
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of 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
Read the detailed description
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.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin, Acetaminophen, Placebo 1, Placebo 2
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called PGB
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.
AcetaminophenDrug
Also called APAP
Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
Placebo 1Other
Placebo for APAP
Placebo 2Other
Placebo for combination
| Study group | Role | What they receive |
|---|---|---|
| PGB and APAP (Group A) | Experimental | Group A receives PGB plus APAP prior to surgery and placebo 1 post-surgery. Receives: Drug: Pregabalin; Drug: Acetaminophen |
| APAP (Group B) | Experimental | Group B receives placebo 2 prior to surgery and APAP post-surgery. Receives: Drug: Acetaminophen; Other: Placebo 2 |
| Placebo (Group C). | Experimental | Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. Receives: Other: Placebo 1; Other: Placebo 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 to 48 hours
Secondary outcomes (12)
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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 7 days
Percentage of Participants Who Were Opioid Free Over Time
Percentages of participants who did not take opioid (rescue medication) over time.
Measured: 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
Measured: 24 hours and 48 hours
Total Consumption of Rescue Medication
The total consumption of rescue analgesia was reported.
Measured: 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).
Measured: 7 days
Percentage of Participants Who Used Rescue Medication
Percentage of participants who used rescue medication is reported
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start28 Jul 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevakar, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nevakar Injectables, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495283
- Sponsor's protocol ID
- CP-NVK009-0005
- Status last verified
- Oct 2021
- First submitted
- 27 Jul 2020
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
- ClinicalTrials.gov ID
- NCT04495283
- Acronym / sponsor ID
- CP-NVK009-0005
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Nevakar, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nevakar Injectables, Inc.
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| PGB and APAP (Group A) | Experimental | Drug: Pregabalin, Drug: AcetaminophenGroup A receives PGB plus APAP prior to surgery and placebo 1 post-surgery. |
| APAP (Group B) | Experimental | Drug: Acetaminophen, Other: Placebo 2Group B receives placebo 2 prior to surgery and APAP post-surgery. |
| Placebo (Group C). | Experimental | Other: Placebo 1, Other: Placebo 2Group C receives placebo 1 prior to surgery and placebo 2 post-surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide informed consent by signing the informed consent form (ICF) approved by the Institutional Review Board (IRB);
- Be male or female aged 18-65 years;
- Be scheduled to undergo unilateral first metatarsal bunionectomy;
- Be in good health and capable of undergoing a bunionectomy under anesthesia as described in the study surgical and anesthetic protocol;
- Weigh between 50 and 100 kg (body mass index [BMI] <32 kg/m2);
Key exclusion criteria (24 listed)
- 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:
- Deep venous thrombosis (DVT) prophylaxis of the surgeon's choice is permitted postoperatively.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: PGBPregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties. | Drug | PGB and APAP (Group A) |
| AcetaminophenAlso: APAPAcetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. | Drug | APAP (Group B), PGB and APAP (Group A) |
| Placebo 1Placebo for APAP | Other | Placebo (Group C). |
| Placebo 2Placebo for combination | Other | APAP (Group B), Placebo (Group C). |
Primary outcome
Summed Pain Intensity (SPI) Between Group A and Group C
Time frame: 0 to 48 hours
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)
12 secondary outcomes
Summed Pain Intensity (SPI) Compared Between Group A and Group B
Time frame: 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).
Time frame: 0, 12, 24, 48 hours
Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time
Time frame: 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)
Time frame: 7 days
Percentage of Participants Who Were Opioid Free Over Time
Time frame: 12 to 48 hours
Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours
Time frame: 24 hours and 48 hours
Total Consumption of Rescue Medication
Time frame: 7 days
Time to First Use of Rescue Medication From Hour 0
Time frame: 7 days
Percentage of Participants Who Used Rescue Medication
Time frame: 7 days
Patient Global Assessment of Pain
Time frame: 48 hours
Maximum Observed Concentration for PGB and APAP
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pregabalin and Acetaminophen in people with Postoperative Pain, run by Nevakar, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed Pain Intensity (SPI) Between Group A and Group C (time frame: 0 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.