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| ID | Type | Description | Link |
|---|---|---|---|
| B3411007 |
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This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Active Comparator |
| |
| Treatment C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen Sodium | Drug | Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet | SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0-3 Hours |
| Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0 to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Meaningful Relief: Remaining Comparisons | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19145 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26819724 | Derived | Packman E, Leyva R, Kellstein D. Onset of analgesia with ibuprofen sodium in tension-type headache: a randomized trial. J Pharm Health Care Sci. 2015 Apr 2;1:13. doi: 10.1186/s40780-015-0012-9. eCollection 2015. | |
| 25526232 | Derived | Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet. |
| FG001 | Ibuprofen (Motrin IB) | Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. |
| FG002 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet. |
| BG001 | Ibuprofen (Motrin IB) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet | SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 0-3 Hours |
|
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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 Sodium | Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006261 | Headache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Standard Ibuprofen |
| Drug |
Single-dose of standard ibuprofen tablets (400mg) |
|
| Placebo | Drug | Single-dose of placebo |
|
| 0 to 3 hours |
| Time to Confirmed First Perceptible Relief | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". | 0 to 3 hours |
| Pain Relief Rating (PRR) | PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | 1, 2 & 3 hours post-dose |
| Pain Intensity Difference (PID) | PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). | 1, 2 & 3 hours post-dose |
| Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). | 1, 2 & 3 hours post-dose |
| Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). | 0 to 2, 0 to 3 hours |
| Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | 0 to 2, 0 to 3 hours |
| Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | 0 to 2, 0 to 3 hours |
| Cumulative Percentage of Participants With Meaningful Relief | Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | 0.5, 1, 2, 3 hours |
| Cumulative Percentage of Participants With First Perceptible Relief | Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". | 0.5, 1, 2, 3 hours |
| Duration of Relief | Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first. | 0 to 3 hours |
| Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | 1, 2, 3 hours post-dose |
| Cumulative Percentage of Participants With Complete Relief | Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief | 1, 2, & 3 hours post-dose |
Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
| BG002 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Severity Score | Pain severity score was assessed on a 4-point categorical scale. Total possible pain severity was 0 to 3, where 0 = none, 1 = mild, 2 = moderately severe and 3 = severe. | Number | participants |
|
Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet. |
| OG001 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. |
|
|
|
| Primary | Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | 0 to 3 hours |
|
|
|
|
| Secondary | Time to Onset of Meaningful Relief: Remaining Comparisons | Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | 0 to 3 hours |
|
|
|
|
| Secondary | Time to Confirmed First Perceptible Relief | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | 0 to 3 hours |
|
|
|
|
| Secondary | Pain Relief Rating (PRR) | PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 1, 2 & 3 hours post-dose |
|
|
|
|
| Secondary | Pain Intensity Difference (PID) | PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 1, 2 & 3 hours post-dose |
|
|
|
|
| Secondary | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) | PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 1, 2 & 3 hours post-dose |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Intensity Difference (SPID) | SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 0 to 2, 0 to 3 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Rating (TOTPAR) | TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 0 to 2, 0 to 3 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) | SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on scale | 0 to 2, 0 to 3 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With Meaningful Relief | Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 0.5, 1, 2, 3 hours |
|
|
|
|
| Secondary | Cumulative Percentage of Participants With First Perceptible Relief | Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 0.5, 1, 2, 3 hours |
|
|
|
|
| Secondary | Duration of Relief | Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first. | Population included all randomized patients that reported a treatment failure or received rescue medication. | Posted | 0 to 3 hours |
|
|
| Secondary | Cumulative Percentage of Participants With Treatment Failure | Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. | ITT population included all randomized patients who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 1, 2, 3 hours post-dose |
|
|
|
| Secondary | Cumulative Percentage of Participants With Complete Relief | Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief | ITT population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Number | percentage of participants | 1, 2, & 3 hours post-dose |
|
|
|
|
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Ibuprofen (Motrin IB) | Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. | 0 | 89 | 0 | 89 |
| EG002 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet. | 0 | 46 | 0 | 46 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| <0.001 |
p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 3.64 |
| 2-Sided |
| 95 |
| 2.23 |
| 5.94 |
| No |
| Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| <0.001 |
p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 3.88 |
| 2-Sided |
| 95 |
| 2.38 |
| 6.34 |
| No |
| Superiority or Other |
| HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. | Proportional hazards model | 0.247 | p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Hazard Ratio (HR) | 1.21 | 2-Sided | 95 | 0.88 | 1.66 | No | Superiority or Other |
|
| 3 hours |
|
|
1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| < 0.001 |
p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Least Square (LS) mean difference |
| 1.27 |
| 2-Sided |
| 95 |
| 0.93 |
| 1.61 |
| No |
| Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.943 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.01 | 2-Sided | 95 | -0.29 | 0.27 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 1.25 | 2-Sided | 95 | 0.89 | 1.62 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 1.22 | 2-Sided | 95 | 0.85 | 1.59 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.847 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.03 | 2-Sided | 95 | -0.27 | 0.33 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 1.59 | 2-Sided | 95 | 1.14 | 2.05 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 1.68 | 2-Sided | 95 | 1.22 | 2.13 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - (Ibuprofen IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.663 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.08 | 2-Sided | 95 | -0.46 | 0.29 | No | Superiority or Other |
|
| 3 hours |
|
|
1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| <0.001 |
p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Least Square (LS) mean difference |
| 0.51 |
| 2-Sided |
| 95 |
| 0.33 |
| 0.69 |
| No |
| Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.651 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.03 | 2-Sided | 95 | -0.11 | 0.18 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.62 | 2-Sided | 95 | 0.42 | 0.81 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.65 | 2-Sided | 95 | 0.46 | 0.85 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.669 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.03 | 2-Sided | 95 | -0.19 | 0.13 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.84 | 2-Sided | 95 | 0.57 | 1.11 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.94 | 2-Sided | 95 | 0.67 | 1.21 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.396 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.10 | 2-Sided | 95 | -0.32 | 0.13 | No | Superiority or Other |
|
| 3 hours |
|
|
1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| <0.001 |
p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Least Square (LS) mean difference |
| 1.78 |
| 2-Sided |
| 95 |
| 1.28 |
| 2.28 |
| No |
| Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.911 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.02 | 2-Sided | 95 | -0.39 | 0.43 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 1.87 | 2-Sided | 95 | 1.33 | 2.41 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 1.88 | 2-Sided | 95 | 1.34 | 2.42 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.982 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.00 | 2-Sided | 95 | -0.45 | 0.44 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 2.44 | 2-Sided | 95 | 1.72 | 3.15 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 2.61 | 2-Sided | 95 | 1.90 | 3.33 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.547 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.18 | 2-Sided | 95 | -0.77 | 0.41 | No | Superiority or Other |
|
|
SPID 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| <0.001 |
p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Least Square (LS) mean difference |
| 1.17 |
| 2-Sided |
| 95 |
| 0.83 |
| 1.50 |
| No |
| Superiority or Other |
| SPID 0-2: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.992 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.00 | 2-Sided | 95 | -0.28 | 0.27 | No | Superiority or Other |
| SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 2.01 | 2-Sided | 95 | 1.43 | 2.58 | No | Superiority or Other |
| SPID 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 2.10 | 2-Sided | 95 | 1.53 | 2.68 | No | Superiority or Other |
| SPID 0-3: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.684 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.10 | 2-Sided | 95 | -0.57 | 0.38 | No | Superiority or Other |
|
|
TOTPAR 0-2: Treatment difference [Ibuprofen (Motrin IB) - Placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| <0.001 |
p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Least Square (LS) mean difference |
| 2.49 |
| 2-Sided |
| 95 |
| 1.83 |
| 3.15 |
| No |
| Superiority or Other |
| TOTPAR 0-2: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.943 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.02 | 2-Sided | 95 | -0.52 | 0.56 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 4.10 | 2-Sided | 95 | 3.03 | 5.18 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference [Ibuprofen (Motrin IB) - Placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 4.17 | 2-Sided | 95 | 3.09 | 5.24 | No | Superiority or Other |
| TOTPAR 0-3: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.888 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.06 | 2-Sided | 95 | -0.95 | 0.82 | No | Superiority or Other |
|
|
SPRID 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. |
| ANOVA |
| <0.001 |
p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). |
| Least Square (LS) mean difference |
| 3.66 |
| 2-Sided |
| 95 |
| 2.68 |
| 4.63 |
| No |
| Superiority or Other |
| SPRID 0-2: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.964 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 0.02 | 2-Sided | 95 | -0.78 | 0.82 | No | Superiority or Other |
| SPRID 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | <0.001 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | 6.27 | 2-Sided | 95 | 4.65 | 7.89 | No | Superiority or Other |
| SPRID 0-3: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model. | ANOVA | 0.812 | p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided). | Least Square (LS) mean difference | -0.16 | 2-Sided | 95 | -1.49 | 1.17 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 2 hours |
|
| 3 hours |
|
| 0.5 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.146 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.50 | 2-Sided | 95 | 0.13 | 8.88 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.064 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.62 | 2-Sided | 95 | -0.38 | 15.63 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 58.58 | 2-Sided | 95 | 44.96 | 72.21 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 52.31 | 2-Sided | 95 | 38.20 | 66.41 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.357 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.40 | 2-Sided | 95 | -7.27 | 20.07 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 46.68 | 2-Sided | 95 | 30.43 | 62.93 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 47.59 | 2-Sided | 95 | 31.35 | 63.83 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.889 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.72 | 2-Sided | 95 | -10.89 | 9.45 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 40.26 | 2-Sided | 95 | 23.85 | 56.68 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 41.19 | 2-Sided | 95 | 24.78 | 57.59 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.889 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.72 | 2-Sided | 95 | -10.89 | 9.45 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 2 hours |
|
| 3 hours |
|
| 0.5 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.055 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.80 | 2-Sided | 95 | 2.14 | 13.46 | No | Superiority or Other |
| 0.5 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.033 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 10.91 | 2-Sided | 95 | 0.98 | 20.83 | No | Superiority or Other |
| 1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 62.03 | 2-Sided | 95 | 48.65 | 75.41 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 59.44 | 2-Sided | 95 | 45.69 | 73.19 | No | Superiority or Other |
| 1 hour: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.642 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 2.96 | 2-Sided | 95 | -9.52 | 15.44 | No | Superiority or Other |
| 2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 40.26 | 2-Sided | 95 | 23.85 | 56.68 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 41.19 | 2-Sided | 95 | 24.78 | 57.59 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.889 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.72 | 2-Sided | 95 | -10.89 | 9.45 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 40.26 | 2-Sided | 95 | 23.85 | 56.68 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 41.19 | 2-Sided | 95 | 24.78 | 57.59 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.889 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.72 | 2-Sided | 95 | -10.89 | 9.45 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 3 hours |
|
| 2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.490 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 2.35 | 2-Sided | 95 | -3.69 | 8.39 | No | Superiority or Other |
| 2 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.764 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 0.98 | 2-Sided | 95 | -5.45 | 7.41 | No | Superiority or Other |
| 3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 28.71 | 2-Sided | 95 | 15.72 | 41.70 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | <0.001 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 29.37 | 2-Sided | 95 | 16.19 | 42.56 | No | Superiority or Other |
| 3 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error. | Cochran-Mantel-Haenszel | 0.898 | p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.93 | 2-Sided | 95 | -15.22 | 13.36 | No | Superiority or Other |