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| Name | Class |
|---|---|
| AAIPharma | INDUSTRY |
| Jean Brown Research | OTHER |
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The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.
This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen 600 mg ER group | Experimental | One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain). |
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| Placebo group | Placebo Comparator | Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 600 mg Extended-Release Tablets | Drug | Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36. |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale | Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID). An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation. | from baseline to 12 hours after dose 1 |
| Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation. | 24, 36, and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Confirmed "First Perceptible" Relief | When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when "initial" relief was observed and again when "meaningful" relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for "No Pain Relief" is 240 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven E Christensen, D.D.S. | Jean Brown Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
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Date First Subject Enrolled: 24 June 2008 Date Last Subject Enrolled: 11 October 2008 All subjects were to receive 4 doses of study drug or placebo at 12-hour intervals. Of the 12 subjects who prematurely discontinued study drug, 6 subjects received 1 dose of study drug, 2 subjects received 2 doses, and 4 subjects received 3 doses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen 600mg ER | Participants received 600 mg 12-hour extended-release tablets twice daily (BID). |
| FG001 | Placebo | Participants received placebo tablet twice daily (BID) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen 600mg ER | Participants received 600 mg 12-hour extended-release tablets twice daily (BID). |
| BG001 | Placebo | Participants received placebo tablet twice daily (BID) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale | Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID). An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation. | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | from baseline to 12 hours after dose 1 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen 600mg ER | Participants received 600 mg 12-hour extended-release tablets twice daily (BID). |
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Of the 12 subjects who prematurely discontinued all 4 doses of the study drug, 6 subjects received 1 dose of study drug, 2 subjects received 2 doses, and 4 subjects received 3 doses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Turner, VP and Chief Technical Officer | SCOLR Pharma Inc | 425-368-1050 | 1001 | sturner@scolr.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36. |
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| Within 4 hours post Dose 1 |
| Time to Confirmed "Meaningful" Relief | When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when "initial" relief was observed and again when "meaningful" relief was achieved. Time to confirmed "meaningful" relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both "initial" and "meaningful" relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain. | Within 4 hours post Dose 1 |
| Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1 | Percentage (percentage of total) of subjects with "first perceptible" relief within 1 hour of Dose 1. The assigned censored time for "No Pain Relief" was 240 minutes. | Within 1 hour of Dose 1 |
| Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief | Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both "first perceptible" relief and "meaningful" relief within the time allotted. The assigned censored time for "No Pain Relief" is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain | Within 4 hours post Dose 1 |
| Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID) | The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived. | 0-12 hours after Dose 1 |
| Duration of Relief After Dose 1 | Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time. | Time to rescue or time of Dose 2 (up to 12 hours following dose 1) |
| Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1 | Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated. | 0-12 hours after taking Dose 1 |
| Pain Relief and PID Scores at Individual Time Points for Dose 1 | Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement) | 24, 36, 48 hours after taking Dose 1 |
| Global Evaluation for Dose 1 | Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command: "Select the number that best describes how you would rate this medication as a pain-reliever (select one number only)." The range went from 0 (Very poor) to 10 (Excellent). | At 12 hours after Dose 1 or at time of rescue |
| Global Evaluation, Maximum Relief, and Overall Relief for Dose 2 | Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief). | At 24 hours or at time of rescue between 12 and 24 hours |
| Global Evaluation, Maximum Relief, and Overall Relief for Dose 3 | Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief). | At 36 hours or at time rescue between 24 and 36 hours |
| Global Evaluation, Maximum Relief, and Overall Relief for Dose 4 | Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief). | At 48 hours or at time of rescue between 36 and 48 hours. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Participants received placebo tablet twice daily (BID) |
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| Primary | Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation. | Intention to treat (ITT) | Posted | Number | participants | 24, 36, and 48 hours |
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| Secondary | Time to Confirmed "First Perceptible" Relief | When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when "initial" relief was observed and again when "meaningful" relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for "No Pain Relief" is 240 minutes. | Intention to treat (ITT) | Posted | Median | Full Range | Minutes | Within 4 hours post Dose 1 |
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| Secondary | Time to Confirmed "Meaningful" Relief | When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when "initial" relief was observed and again when "meaningful" relief was achieved. Time to confirmed "meaningful" relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both "initial" and "meaningful" relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain. | Intention to treat (ITT) | Posted | Median | Full Range | Minutes | Within 4 hours post Dose 1 |
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| Secondary | Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1 | Percentage (percentage of total) of subjects with "first perceptible" relief within 1 hour of Dose 1. The assigned censored time for "No Pain Relief" was 240 minutes. | Intention to treat (ITT) | Posted | Number | 95% Confidence Interval | Percent of participants | Within 1 hour of Dose 1 |
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| Secondary | Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief | Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both "first perceptible" relief and "meaningful" relief within the time allotted. The assigned censored time for "No Pain Relief" is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain | Intention to treat (ITT) | Posted | Number | 95% Confidence Interval | Percent of participants | Within 4 hours post Dose 1 |
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| Secondary | Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID) | The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived. | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Time weighted units on a scale | 0-12 hours after Dose 1 |
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| Secondary | Duration of Relief After Dose 1 | Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time. | Intention to treat (ITT) | Posted | Median | Full Range | Minutes | Time to rescue or time of Dose 2 (up to 12 hours following dose 1) |
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| Secondary | Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1 | Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated. | Intention to treat (ITT) | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of participants | 0-12 hours after taking Dose 1 |
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| Secondary | Pain Relief and PID Scores at Individual Time Points for Dose 1 | Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement) | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | 24, 36, 48 hours after taking Dose 1 |
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| Secondary | Global Evaluation for Dose 1 | Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command: "Select the number that best describes how you would rate this medication as a pain-reliever (select one number only)." The range went from 0 (Very poor) to 10 (Excellent). | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | At 12 hours after Dose 1 or at time of rescue |
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| Secondary | Global Evaluation, Maximum Relief, and Overall Relief for Dose 2 | Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief). | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | At 24 hours or at time of rescue between 12 and 24 hours |
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| Secondary | Global Evaluation, Maximum Relief, and Overall Relief for Dose 3 | Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief). | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | At 36 hours or at time rescue between 24 and 36 hours |
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| Secondary | Global Evaluation, Maximum Relief, and Overall Relief for Dose 4 | Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief). | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | At 48 hours or at time of rescue between 36 and 48 hours. |
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| 0 |
| 169 |
| 0 |
| 169 |
| EG001 | Placebo | Participants received placebo tablet twice daily (BID) | 0 | 87 | 0 | 87 |
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| D010335 | Pathologic Processes |
Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel
| 95 |
| No |
| Superiority or Other |
| TOTPAR 4-8 hours |
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| TOTPAR 4-12 hours |
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| SPID 0-12 hours |
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| SPID 0-4 hours |
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| SPID 4-8 hours |
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| SPID 4-12 hours |
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| Rescue at or prior to 12 hours after dose 1 |
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| 48 hours after dose 1. |
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| Overall Relief for Dose 2 |
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| Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief. | ANCOVA | <0.0001 | P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories. | 95 | No | Superiority or Other |
| Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief. | ANCOVA | <0.0001 | P-value from ANCOVA with terms for treatment, gender and baseline pain score categories. | 95 | No | Superiority or Other |
| Overall Relief for Dose 3 |
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| Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief. | ANCOVA | <0.0001 | P-value from ANCOVA with terms for treatment, gender and basee pain score categories. | 95 | No | Superiority or Other |
| Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief. | ANCOVA | <0.0001 | P-value from ANCOVA with terms for treatment, gender and baseline pain score categories. | 95 | No | Superiority or Other |
| Overall Relief for Dose 4 |
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| Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief. | ANCOVA | <0.0001 | P-value from ANCOVA with terms for treatment, gender and baseline pain score categories. | 95 | No | Superiority or Other |
| Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief. | ANCOVA | <0.0001 | P-value from ANCOVA with terms for treatment, gender and baseline pain score categories. | 95 | No | Superiority or Other |