Trial · NCT04495283
A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
NCT04495283, Phase 2, Completed, Nevakar, Inc.; results first posted 2021-11-23
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy. Trials, record NCT04495283. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04495283
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
- NCT number
- NCT04495283
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Nevakar, Inc.
- Conditions
- Postoperative Pain
- Interventions
- Pregabalin, Acetaminophen, Placebo 1, Placebo 2
- First posted
- 2020-07-31
- Last updated
- 2021-11-23
- Results first posted
- 2021-11-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summed Pain Intensity (SPI) Between Group A and Group C | 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) |
| Secondary | Summed Pain Intensity (SPI) Compared Between Group A and Group B | 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, 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) |
| 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). | 0, 12, 24, 48 hours | 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. |
| Secondary | Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time | 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours | 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. |
| Secondary | Number of Participants With Treatment-Related Adverse Events (TRAE) | 7 days | 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 |
| Secondary | Percentage of Participants Who Were Opioid Free Over Time | 12 to 48 hours | Percentages of participants who did not take opioid (rescue medication) over time. |
| Secondary | Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours | 24 hours and 48 hours | The total consumption of opioid rescue analgesia through 24 hours and through 48 hours was reported |
| Secondary | Total Consumption of Rescue Medication | 7 days | The total consumption of rescue analgesia was reported. |
| Secondary | Time to First Use of Rescue Medication From Hour 0 | 7 days | 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). |
| Secondary | Percentage of Participants Who Used Rescue Medication | 7 days | Percentage of participants who used rescue medication is reported |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summed Pain Intensity (SPI) Between Group A and Group C | 0 to 48 hours | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity (SPI) Compared Between Group A and Group B | 0 to 48 hours | 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. | score on a scale | LEAST_SQUARES_MEAN |
| 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). | 0, 12, 24, 48 hours | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time | 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours | 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. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events (TRAE) | 7 days | 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 | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Opioid Free Over Time | 12 to 48 hours | 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. | percentage of participants | NUMBER |
| SECONDARY | Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours | 24 hours and 48 hours | 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. | oral morphine equivalents | MEAN |
| SECONDARY | Total Consumption of Rescue Medication | 7 days | 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. | oral morphine equivalents | MEAN |
| SECONDARY | Time to First Use of Rescue Medication From Hour 0 | 7 days | 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. | hours | MEDIAN |
| SECONDARY | Percentage of Participants Who Used Rescue Medication | 7 days | 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. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summed Pain Intensity (SPI) Between Group A and Group C | PGB and APAP (Group A) | 153.08 | Standard Error 15.238 | score on a scale | |
| Summed Pain Intensity (SPI) Between Group A and Group C | Placebo (Group C). | 267.51 | Standard Error 21.864 | score on a scale | |
| Summed Pain Intensity (SPI) Compared Between Group A and Group B | PGB and APAP (Group A) | 153.08 | Standard Error 15.238 | score on a scale | |
| Summed Pain Intensity (SPI) Compared Between Group A and Group B | APAP (Group B) | 223.24 | Standard Error 5.238 | score on a scale | |
| 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). | PGB and APAP (Group A) | SPI 0-12 | 33.09 | Standard Error 3.728 | score on a scale |
| 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). | APAP (Group B) | SPI 0-12 | 49.09 | Standard Error 3.728 | score on a scale |
| 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). | Placebo (Group C). | SPI 0-12 | 58.89 | Standard Error 5.349 | score on a scale |
| 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). | PGB and APAP (Group A) | SPI 12-24 | 50.92 | Standard Error 5.082 | score on a scale |
| 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). | APAP (Group B) | SPI 12-24 | 69.35 | Standard Error 5.082 | score on a scale |
| 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). | Placebo (Group C). | SPI 12-24 | 88.95 | Standard Error 7.292 | score on a scale |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PGB and APAP (Group A) | 35 | |
| Overall Study | STARTED | APAP (Group B) | 35 | |
| Overall Study | STARTED | Placebo (Group C). | 17 | |
| Overall Study | COMPLETED | PGB and APAP (Group A) | 34 | |
| Overall Study | COMPLETED | APAP (Group B) | 34 | |
| Overall Study | COMPLETED | Placebo (Group C). | 14 | |
| Overall Study | NOT COMPLETED | PGB and APAP (Group A) | 1 | |
| Overall Study | NOT COMPLETED | APAP (Group B) | 1 | |
| Overall Study | NOT COMPLETED | Placebo (Group C). | 3 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | PGB and APAP (Group A) | 0 | 35 | |
| other | Tachycardia | Cardiac disorders | APAP (Group B) | 1 | 35 | |
| other | Tachycardia | Cardiac disorders | Placebo (Group C). | 0 | 17 | |
| other | Diplopia | Eye disorders | PGB and APAP (Group A) | 1 | 35 | |
| other | Diplopia | Eye disorders | APAP (Group B) | 0 | 35 | |
| other | Diplopia | Eye disorders | Placebo (Group C). | 0 | 17 | |
| other | Vision blurred | Eye disorders | PGB and APAP (Group A) | 1 | 35 | |
| other | Vision blurred | Eye disorders | APAP (Group B) | 0 | 35 | |
| other | Vision blurred | Eye disorders | Placebo (Group C). | 0 | 17 | |
| other | Constipation | Gastrointestinal disorders | PGB and APAP (Group A) | 0 | 35 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PGB and APAP (Group A) | 0 | 35 |
| Total, all-cause mortality | APAP (Group B) | 0 | 35 |
| Total, all-cause mortality | Placebo (Group C). | 0 | 17 |
| Total, other adverse events | PGB and APAP (Group A) | 27 | 35 |
| Total, other adverse events | APAP (Group B) | 15 | 35 |
| Total, other adverse events | Placebo (Group C). | 9 | 17 |
| Total, serious adverse events | PGB and APAP (Group A) | 0 | 35 |
| Total, serious adverse events | APAP (Group B) | 0 | 35 |
| Total, serious adverse events | Placebo (Group C). | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT04495283
GET https://conductscience.org/api/trials/v1/NCT04495283/results?page=2