| Primary | Time to Confirmed Perceptible Pain Relief | Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Median | Full Range | minutes | | within 4 hours | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally | | OG002 | Commercial ACM 1000 mg | Two commercial acetaminophen 500 mg caplets taken orally | | OG003 | Commercial IBU 400 mg | Two commercial ibuprofen 200 mg liquid-filled capsules taken orally |
| | Units | Counts |
|---|
| Participants | - OG00059
- OG001249
- OG002232
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000NA(4.9 to 240)The median time to confirmed perceptible pain relief was not estimable since fewer than 50% of the participants treated with Placebo obtained confirmed perceptible pain relief.
- OG00115.7(2.2 to 240)
- OG002
|
|
| | 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 |
|---|
| | Wilcoxon test from SAS PROC LIFETEST | | <0.001 | The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves. | | | | | | | | | | | | | Superiority | | | | | Wilcoxon test from SAS PROC LIFETEST |
|
| Secondary | Time to Meaningful Pain Relief | Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Median | Full Range | minutes | | Within 4 hours | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally | | OG002 | Commercial ACM 1000 mg | Two commercial acetaminophen 500 mg caplets taken orally | | OG003 | Commercial IBU 400 mg | Two commercial ibuprofen 200 mg liquid-filled capsules taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes | Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 30 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes | Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 29 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes | Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 28 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes | Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 27 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes | Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 26 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes | Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 25 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes | Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 24 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes | Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 23 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes | Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 22 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes | Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 21 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes | Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 20 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes | Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 19 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes | Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 18 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes | Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 17 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes | Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 16 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes | Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 15 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes | Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 14 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes | Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 13 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes | Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 12 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |
| Secondary | Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes | Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. | Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized. | Posted | | Number | | Percentage of Participants | | by 11 minutes | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo caplets taken orally | | OG001 | Test ACM 1000 mg | Two test acetaminophen 500 mg tablets taken orally |
| |