| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | Score on scale * hour | | 0-24 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000116.9± 5.55
- OG001129.0± 5.58
- OG002127.4± 5.52
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | 0.1683 | | LSM difference | -10.5 | Standard Error of the Mean | 7.61 | 2-Sided | 95 | -25.4 | 4.4 | | | | | Superiority | | | | | ANOVA | | 0.8356 |
|
| Secondary | Time to First Rescue Medication Use After Time 0 (When First Dose on Day 1 is Administered) | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Mean | Standard Error | hours | | 0-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Were Opioid Free Through 24 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-24 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Were Opioid Free Through 48 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Were Opioid Free Through 72 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | Score on scale * hour | | 0-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD |
|
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | Score on scale * hour | | 0-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD |
|
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | Score on scale * hour | | 0-4 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | |
|
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | Score on scale * hour | | 0-6 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | |
|
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | Score on scale * hour | | 0-12 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD |
|
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | score on a scale * hour | | 24-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | |
|
| 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. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | score on a scale * hour | | 48-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | |
|
| Secondary | Rescue Medication Taken During 0-24 Hours | Number of instances of rescue medication taken during first 24 hours. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | instances | | 0-24 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Rescue Medication Taken During 24-48 Hours | Number of instances of rescue medication taken during 24-48 hours. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | instances | | 24-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Rescue Medication Taken During 48-72 Hours | Number of instances of rescue medication taken during 48-72 hours. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | instances | | 48-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Rescue Medication Taken During 0-48 Hours | Number of instances of rescue medication taken during first 48 hours. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | instances | | 0-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Rescue Medication Taken During 0-72 Hours | Number of instances of rescue medication taken during first 72 hours. | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | instances | | 0-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Did Not Use Rescue Medication Through 24 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-24 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Did Not Use Rescue Medication Through 48 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Did Not Use Rescue Medication Through 72 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-72 Hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 24 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-24 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 48 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Are Pain Free (NRS ≤2) at 72 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 0-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Number of Hours Subjects Are Pain Free (NRS ≤2) | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | hours | | 0-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Were Opioid Free During 24-48 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 24-48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| Secondary | Proportion of Subjects Who Were Opioid Free During 48-72 Hours | | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Count of Participants | | Participants | | 48-72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| 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 | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | score on a scale | | First rescue medication dose, up to 24 hours post first dose. | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| 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 | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | score on a scale | | 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| 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 | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | score on a scale | | 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |
| 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 | Two subjects in the ACP-044 Q6H group were included in the safety analysis set but not the full analysis set. | Posted | | Least Squares Mean | Standard Error | score on a scale | | 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Drug - ACP-044 400 mg Q6H | ACP-044 Dose A ACP-044 Dose A: Oral dose of ACP-044 400 mg Q6H | | OG001 | Drug - ACP-044 1600 mg QD | ACP-044 Dose B ACP-044 Dose B: Oral dose of ACP-044 1600 mg QD | | OG002 | Placebo | Placebo Placebo: Oral dose of placebo |
| |