Acute Postoperative Pain, Bunionectomy
Conditions
Brief summary
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain
Interventions
DRUGACP-044 Dose A
Oral dose of ACP-044 Dose A
DRUGACP-044 Dose B
Oral dose of ACP-044 Dose B
DRUGPlacebo
Oral dose of placebo
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥18 and \<60 years of age at the time of Screening * Has a body mass index (BMI) \<40 kg/m2 * Able to understand and provide signed informed consent * Able to complete subject-reported outcome measures * Is in need of a primary unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia and sedation * Willing to remain inpatient at the study center for 4 days following surgery
Exclusion criteria
* Has had a contralateral foot bunionectomy in the past 3 months * Has a planned concurrent surgical procedure (e.g. bilateral bunionectomy or collateral procedures like hammertoe correction on the surgical foot) * Any subacute or chronic pain condition or use of a medication that would impair/impact the ability to rate the pain associated with the bunionectomy, in the opinion of the Investigator and Medical Monitor * Has known or suspected regular use of opioids within the previous 6 months * Has taken opioids within 24 hours prior to the scheduled surgery or within five half-lives of the drug, whichever is longer * Has a known or suspected history of drug abuse, a positive drug screen at Screening or Day -1, or a recent (i.e., within the last 5 years) history of alcohol abuse. Subjects using marijuana are not allowed to participate in the study. * Has taken any aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 days prior to the scheduled surgery or within five half-lives of the drug, whichever is longer * Has initiated treatment with any medications within 1 month prior to study drug administration that could impact pain control or quantitation of their pain response * Has been administered systemic steroids within five half-lives or 10 days prior to administration of study drug, whichever is longer * Has current evidence, or medical history of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, endocrinologic, or other medical disorder, within the previous 12 weeks prior to Screening and on Day -1, that in the judgment of the Investigator and/or Medical Monitor would jeopardize the safe participation of the subject in the study. Also, subject must not have had a malignancy in the last year, with the exception of nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix. * Is judged by the Investigator or the Medical Monitor to be inappropriate for the study Additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 Hours | 0-24 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours | 0-72 hours | — |
| Number of Hours Subjects Are Pain Free (NRS ≤2) | 0-72 hours | — |
| Proportion of Subjects Who Were Opioid Free During 24-48 Hours | 24-48 hours | — |
| Proportion of Subjects Who Were Opioid Free During 48-72 Hours | 48-72 hours | — |
| Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered) | 0-72 hours | — |
| Proportion of Subjects Who Were Opioid Free Through 24 Hours | 0-24 hours | — |
| Proportion of Subjects Who Were Opioid Free Through 48 Hours | 0-48 hours | — |
| Proportion of Subjects Who Were Opioid Free Through 72 Hours | 0-72 hours | — |
| Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044 | 0-48 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 30, 36, 42, and 48 hours. |
| Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044 | 0-72 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, and 72 hours. |
| Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours | 0-48 hours | — |
| Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044 | 0-4 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, and 4 hours. |
| Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours | 0-72 Hours | — |
| Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours | 0-24 hours | — |
| Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours | 0-48 hours | — |
| Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044 | 0-12 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours. |
| Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044 | 24-48 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 24, 30, 36, 42, and 48 hours. |
| Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044 | 48-72 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 48, 54, 60, 66, and 72 hours. |
| Rescue Medication Taken During 0-24 Hours | 0-24 hours | Number of instances of rescue medication taken during first 24 hours. |
| Rescue Medication Taken During 24-48 Hours | 24-48 hours | Number of instances of rescue medication taken during 24-48 hours. |
| Rescue Medication Taken During 48-72 Hours | 48-72 hours | Number of instances of rescue medication taken during 48-72 hours. |
| Rescue Medication Taken During 0-48 Hours | 0-48 hours | Number of instances of rescue medication taken during first 48 hours. |
| Rescue Medication Taken During 0-72 Hours | 0-72 hours | Number of instances of rescue medication taken during first 72 hours. |
| Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours | 0-24 hours | — |
| Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered) | First rescue medication dose, up to 24 hours post first dose. | 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent |
| Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 24 hours | 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent |
| Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 48 hours | 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent |
| Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 72 hours | 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent |
| Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044 | 0-6 hours | Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, and 6 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug - ACP-044 400 mg Q6H ACP-044 Dose A
ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | 81 |
| Drug - ACP-044 1600 mg QD ACP-044 Dose B
ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | 78 |
| Placebo Placebo
Placebo: Oral dose of placebo | 80 |
| Total | 239 |
Baseline characteristics
| Characteristic | Total | Placebo | Drug - ACP-044 1600 mg QD | Drug - ACP-044 400 mg Q6H |
|---|---|---|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 11.73 | 42.7 years STANDARD_DEVIATION 11.46 | 46.9 years STANDARD_DEVIATION 10.93 | 42.9 years STANDARD_DEVIATION 12.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 70 Participants | 22 Participants | 26 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 58 Participants | 52 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Primary Race American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Primary Race Asian | 8 Participants | 3 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Primary Race Black or African American | 47 Participants | 17 Participants | 14 Participants | 16 Participants |
| Race/Ethnicity, Customized Primary Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Primary Race Other | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Primary Race White | 178 Participants | 58 Participants | 58 Participants | 62 Participants |
| Region of Enrollment United States | 239 participants | 80 participants | 78 participants | 81 participants |
| Sex: Female, Male Female | 196 Participants | 63 Participants | 65 Participants | 68 Participants |
| Sex: Female, Male Male | 43 Participants | 17 Participants | 13 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 78 | 0 / 80 |
| other Total, other adverse events | 25 / 81 | 26 / 78 | 27 / 80 |
| serious Total, serious adverse events | 1 / 81 | 1 / 78 | 0 / 80 |
Outcome results
Primary
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 Hours
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24 hours.
Time frame: 0-24 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 Hours | 116.9 Score on scale * hour | Standard Error 5.55 |
| Drug - ACP-044 1600 mg QD | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 Hours | 129.0 Score on scale * hour | Standard Error 5.58 |
| Placebo | Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) of Pain Intensity Scores From Time 0 (When First Dose on Day 1 is Administered) Through 24 Hours | 127.4 Score on scale * hour | Standard Error 5.52 |
p-value: 0.168395% CI: [-25.4, 4.4]ANOVA
p-value: 0.835695% CI: [-13.4, 16.6]ANOVA
Secondary
Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time frame: 24 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 1.7 score on a scale | Standard Error 0.16 |
| Drug - ACP-044 1600 mg QD | Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.0 score on a scale | Standard Error 0.16 |
| Placebo | Global Evaluation of Study Drug at the End of 24 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 1.7 score on a scale | Standard Error 0.16 |
p-value: 0.902295% CI: [-0.4, 0.5]ANOVA
p-value: 0.24595% CI: [-0.2, 0.7]ANOVA
Secondary
Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time frame: 48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.2 score on a scale | Standard Error 0.15 |
| Drug - ACP-044 1600 mg QD | Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.2 score on a scale | Standard Error 0.15 |
| Placebo | Global Evaluation of Study Drug at the End of 48 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.0 score on a scale | Standard Error 0.15 |
p-value: 0.420595% CI: [-0.2, 0.6]ANOVA
p-value: 0.433695% CI: [-0.2, 0.6]ANOVA
Secondary
Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time frame: 72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.3 score on a scale | Standard Error 0.16 |
| Drug - ACP-044 1600 mg QD | Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.4 score on a scale | Standard Error 0.16 |
| Placebo | Global Evaluation of Study Drug at the End of 72 Hours Relative to Time 0 (When First Dose on Day 1 is Administered) | 2.1 score on a scale | Standard Error 0.16 |
p-value: 0.271895% CI: [-0.2, 0.7]ANOVA
p-value: 0.172795% CI: [-0.1, 0.7]ANOVA
Secondary
Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered)
5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent
Time frame: First rescue medication dose, up to 24 hours post first dose.
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered) | 1.2 score on a scale | Standard Error 0.16 |
| Drug - ACP-044 1600 mg QD | Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered) | 1.5 score on a scale | Standard Error 0.15 |
| Placebo | Global Evaluation of Study Drug Just Before Time of First Rescue Medication Relative to Time 0 (When First Dose on Day 1 is Administered) | 1.2 score on a scale | Standard Error 0.15 |
p-value: 0.846195% CI: [-0.5, 0.4]ANOVA
p-value: 0.172795% CI: [-0.1, 0.7]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 24, 30, 36, 42, and 48 hours.
Time frame: 24-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044 | 90.2 score on a scale * hour | Standard Error 6.29 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044 | 100.8 score on a scale * hour | Standard Error 6.32 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From 24 Through 48 Hours for ACP-044 | 97.3 score on a scale * hour | Standard Error 6.24 |
p-value: 0.409495% CI: [-24, 9.8]ANOVA
p-value: 0.690195% CI: [-13.5, 20.4]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours.
Time frame: 0-12 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044 | 61.7 Score on scale * hour | Standard Error 3.18 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044 | 66.6 Score on scale * hour | Standard Error 3.19 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 12 Hours for ACP-044 | 65.9 Score on scale * hour | Standard Error 3.15 |
p-value: 0.329995% CI: [-12.8, 4.3]ANOVA
p-value: 0.882295% CI: [-7.9, 9.2]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 30, 36, 42, and 48 hours.
Time frame: 0-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044 | 206.8 Score on scale * hour | Standard Error 11.21 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044 | 229.7 Score on scale * hour | Standard Error 11.27 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 48 Hours for ACP-044 | 224.5 Score on scale * hour | Standard Error 11.12 |
p-value: 0.249495% CI: [-47.8, 12.4]ANOVA
p-value: 0.738595% CI: [-25.1, 35.4]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, and 4 hours.
Time frame: 0-4 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044 | 18.3 Score on scale * hour | Standard Error 1.25 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044 | 20.5 Score on scale * hour | Standard Error 1.26 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 4 Hours for ACP-044 | 18.6 Score on scale * hour | Standard Error 1.24 |
p-value: 0.848995% CI: [-3.7, 3]ANOVA
p-value: 0.276895% CI: [-1.5, 5.3]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, and 6 hours.
Time frame: 0-6 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044 | 28.6 Score on scale * hour | Standard Error 1.86 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044 | 32.4 Score on scale * hour | Standard Error 1.86 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 6 Hours for ACP-044 | 29.8 Score on scale * hour | Standard Error 1.84 |
p-value: 0.629195% CI: [-6.2, 3.8]ANOVA
p-value: 0.318295% CI: [-2.5, 7.5]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, and 72 hours.
Time frame: 0-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044 | 274.3 Score on scale * hour | Standard Error 16.72 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044 | 304.7 Score on scale * hour | Standard Error 16.81 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From Time 0 Through 72 Hours for ACP-044 | 296.9 Score on scale * hour | Standard Error 16.59 |
p-value: 0.323895% CI: [-67.5, 22.3]ANOVA
p-value: 0.734495% CI: [-37.3, 52.9]ANOVA
Secondary
Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: Please describe your foot pain at the present time from 0 to 10 where 0 means no pain at all and 10 means the worst pain imaginable. The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 48, 54, 60, 66, and 72 hours.
Time frame: 48-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044 | 67.9 score on a scale * hour | Standard Error 6.27 |
| Drug - ACP-044 1600 mg QD | Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044 | 75.4 score on a scale * hour | Standard Error 6.32 |
| Placebo | Mean AUC of the NRS of Pain Intensity Scores From Time 48 Through 72 Hours for ACP-044 | 73.0 score on a scale * hour | Standard Error 6.22 |
p-value: 0.553695% CI: [-21.9, 11.7]ANOVA
p-value: 0.781195% CI: [-14.5, 19.3]ANOVA
Secondary
Number of Hours Subjects Are Pain Free (NRS ≤2)
Time frame: 0-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Number of Hours Subjects Are Pain Free (NRS ≤2) | 29.0 hours | Standard Error 2.48 |
| Drug - ACP-044 1600 mg QD | Number of Hours Subjects Are Pain Free (NRS ≤2) | 22.8 hours | Standard Error 2.49 |
| Placebo | Number of Hours Subjects Are Pain Free (NRS ≤2) | 23.0 hours | Standard Error 2.46 |
p-value: 0.089795% CI: [-0.9, 12.8]ANOVA
p-value: 0.943495% CI: [-7.1, 6.7]ANOVA
Secondary
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours
Time frame: 0-24 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours | 30 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours | 19 Participants |
| Placebo | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours | 22 Participants |
p-value: 0.711795% CI: [-0.06, 0.24]Cochran-Mantel-Haenszel
p-value: 0.759995% CI: [-0.19, 0.1]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours
Time frame: 0-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours | 42 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours | 37 Participants |
| Placebo | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours | 41 Participants |
p-value: 0.70795% CI: [-0.16, 0.16]Cochran-Mantel-Haenszel
p-value: 0.687795% CI: [-0.2, 0.12]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours
Time frame: 0-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours | 50 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours | 49 Participants |
| Placebo | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours | 55 Participants |
p-value: 0.86995% CI: [-0.22, 0.07]Cochran-Mantel-Haenszel
p-value: 0.37995% CI: [-0.19, 0.1]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours
Time frame: 0-24 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours | 16 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours | 10 Participants |
| Placebo | Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours | 10 Participants |
p-value: 0.168695% CI: [-0.04, 0.19]Cochran-Mantel-Haenszel
p-value: 0.833395% CI: [-0.1, 0.11]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours
Time frame: 0-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours | 16 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours | 9 Participants |
| Placebo | Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours | 9 Participants |
p-value: 0.193995% CI: [-0.02, 0.2]Cochran-Mantel-Haenszel
p-value: 0.959595% CI: [-0.1, 0.1]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours
Time frame: 0-72 Hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours | 16 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours | 9 Participants |
| Placebo | Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours | 9 Participants |
p-value: 0.189495% CI: [-0.02, 0.2]Cochran-Mantel-Haenszel
p-value: 0.959595% CI: [-0.1, 0.1]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Were Opioid Free During 24-48 Hours
Time frame: 24-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Were Opioid Free During 24-48 Hours | 65 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Were Opioid Free During 24-48 Hours | 59 Participants |
| Placebo | Proportion of Subjects Who Were Opioid Free During 24-48 Hours | 59 Participants |
p-value: 0.835595% CI: [-0.04, 0.21]Cochran-Mantel-Haenszel
p-value: 0.356195% CI: [-0.12, 0.15]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Were Opioid Free During 48-72 Hours
Time frame: 48-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Were Opioid Free During 48-72 Hours | 72 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Were Opioid Free During 48-72 Hours | 65 Participants |
| Placebo | Proportion of Subjects Who Were Opioid Free During 48-72 Hours | 70 Participants |
p-value: 0.941395% CI: [-0.06, 0.13]Cochran-Mantel-Haenszel
p-value: 0.781995% CI: [-0.15, 0.07]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Were Opioid Free Through 24 Hours
Time frame: 0-24 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Were Opioid Free Through 24 Hours | 48 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Were Opioid Free Through 24 Hours | 34 Participants |
| Placebo | Proportion of Subjects Who Were Opioid Free Through 24 Hours | 40 Participants |
p-value: 0.245795% CI: [-0.05, 0.26]Cochran-Mantel-Haenszel
p-value: 0.399795% CI: [-0.22, 0.09]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Were Opioid Free Through 48 Hours
Time frame: 0-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Were Opioid Free Through 48 Hours | 45 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Were Opioid Free Through 48 Hours | 32 Participants |
| Placebo | Proportion of Subjects Who Were Opioid Free Through 48 Hours | 40 Participants |
p-value: 0.477195% CI: [-0.09, 0.22]Cochran-Mantel-Haenszel
p-value: 0.292595% CI: [-0.24, 0.06]Cochran-Mantel-Haenszel
Secondary
Proportion of Subjects Who Were Opioid Free Through 72 Hours
Time frame: 0-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug - ACP-044 400 mg Q6H | Proportion of Subjects Who Were Opioid Free Through 72 Hours | 44 Participants |
| Drug - ACP-044 1600 mg QD | Proportion of Subjects Who Were Opioid Free Through 72 Hours | 31 Participants |
| Placebo | Proportion of Subjects Who Were Opioid Free Through 72 Hours | 39 Participants |
p-value: 0.462895% CI: [-0.09, 0.22]Cochran-Mantel-Haenszel
p-value: 0.30995% CI: [-0.24, 0.06]Cochran-Mantel-Haenszel
Secondary
Rescue Medication Taken During 0-24 Hours
Number of instances of rescue medication taken during first 24 hours.
Time frame: 0-24 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Rescue Medication Taken During 0-24 Hours | 2.1 instances | Standard Error 0.21 |
| Drug - ACP-044 1600 mg QD | Rescue Medication Taken During 0-24 Hours | 2.6 instances | Standard Error 0.21 |
| Placebo | Rescue Medication Taken During 0-24 Hours | 2.3 instances | Standard Error 0.21 |
p-value: 0.526795% CI: [-0.8, 0.4]ANOVA
p-value: 0.322895% CI: [-0.3, 0.9]ANOVA
Secondary
Rescue Medication Taken During 0-48 Hours
Number of instances of rescue medication taken during first 48 hours.
Time frame: 0-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Rescue Medication Taken During 0-48 Hours | 3.1 instances | Standard Error 0.35 |
| Drug - ACP-044 1600 mg QD | Rescue Medication Taken During 0-48 Hours | 3.7 instances | Standard Error 0.35 |
| Placebo | Rescue Medication Taken During 0-48 Hours | 3.3 instances | Standard Error 0.35 |
p-value: 0.600395% CI: [-1.2, 0.7]ANOVA
p-value: 0.408695% CI: [-0.6, 1.4]ANOVA
Secondary
Rescue Medication Taken During 0-72 Hours
Number of instances of rescue medication taken during first 72 hours.
Time frame: 0-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Rescue Medication Taken During 0-72 Hours | 3.6 instances | Standard Error 0.43 |
| Drug - ACP-044 1600 mg QD | Rescue Medication Taken During 0-72 Hours | 4.4 instances | Standard Error 0.43 |
| Placebo | Rescue Medication Taken During 0-72 Hours | 4.0 instances | Standard Error 0.43 |
p-value: 0.495895% CI: [-1.6, 0.8]ANOVA
p-value: 0.459595% CI: [-0.8, 1.7]ANOVA
Secondary
Rescue Medication Taken During 24-48 Hours
Number of instances of rescue medication taken during 24-48 hours.
Time frame: 24-48 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Rescue Medication Taken During 24-48 Hours | 1.0 instances | Standard Error 0.17 |
| Drug - ACP-044 1600 mg QD | Rescue Medication Taken During 24-48 Hours | 1.2 instances | Standard Error 0.17 |
| Placebo | Rescue Medication Taken During 24-48 Hours | 1.1 instances | Standard Error 0.17 |
p-value: 0.761795% CI: [-0.5, 0.4]ANOVA
p-value: 0.624195% CI: [-0.4, 0.6]ANOVA
Secondary
Rescue Medication Taken During 48-72 Hours
Number of instances of rescue medication taken during 48-72 hours.
Time frame: 48-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Rescue Medication Taken During 48-72 Hours | 0.5 instances | Standard Error 0.12 |
| Drug - ACP-044 1600 mg QD | Rescue Medication Taken During 48-72 Hours | 0.7 instances | Standard Error 0.12 |
| Placebo | Rescue Medication Taken During 48-72 Hours | 0.6 instances | Standard Error 0.12 |
p-value: 0.344295% CI: [-0.5, 0.2]ANOVA
p-value: 0.789695% CI: [-0.3, 0.4]ANOVA
Secondary
Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered)
Time frame: 0-72 hours
Population: Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug - ACP-044 400 mg Q6H | Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered) | 6.0 hours | Standard Error 0.5 |
| Drug - ACP-044 1600 mg QD | Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered) | 5.7 hours | Standard Error 0.7 |
| Placebo | Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered) | 7.0 hours | Standard Error 0.7 |
p-value: 0.22895% CI: [0.598, 1.155]Log Rank
p-value: 0.560495% CI: [0.793, 1.527]Log Rank