Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 episodic tension-type headache.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Active Comparator |
| |
| Treatment C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Ibuprofen | Drug | Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo |
|
| 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 to 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ibuprofen Sodium |
| 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 a scale | 0 to 3 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| D006261 | Headache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Ibuprofen | Drug | Single-dose of standard ibuprofen (400mg) plus placebo |
|
| 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 |
| 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 |
| 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 |
| 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 Confirmed 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 |
| Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or received 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. | 0 to 3 hours |
| 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 |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of Participants with Pain Severity Score | Pain severity score was assessed on a 4-point categorical scale. Total possible pain severity score range was 0 to 3, where 0 = none, 1 = mild, 2 = moderately severe and 3 = severe. | Number | Participants |
|
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. |
| OG001 | 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. |
|
|
|
| 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 a scale | 1, 2, 3 hours |
|
|
|
|
| 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 a scale | 1, 2, 3 hours |
|
|
|
|
| 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 a scale | 1, 2, 3 hours |
|
|
|
|
| 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 a 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 a 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 a 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 Confirmed 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 | Time to Treatment Failure | Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first. | Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study. | Posted | Median | 95% Confidence Interval | Minutes | 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. | Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study. | Posted | Number | Percentage of participants | 0 to 3 hours |
|
|
| 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 |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 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. | 0 | 79 | 0 | 79 |
| EG002 | 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 | 80 | 0 | 80 |
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.
| No |
| Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| 0.936 |
p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 1.02 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.59 |
| No |
| Superiority or Other |
HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. |
| Proportional hazards model |
| 0.652 |
p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| Hazard Ratio (HR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.58 |
| 1.41 |
| No |
| Superiority or Other |
| HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. | Proportional hazards model | 0.108 | p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | Hazard Ratio (HR) | 0.73 | 2-Sided | 95 | 0.49 | 1.07 | 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 |
| 0.407 |
p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| -0.19 |
| 2-Sided |
| 95 |
| -0.64 |
| 0.26 |
| 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 | 0.991 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.00 | 2-Sided | 95 | -0.38 | 0.37 | 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 | 0.313 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.25 | 2-Sided | 95 | -0.75 | 0.24 | 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 | 0.621 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.12 | 2-Sided | 95 | -0.62 | 0.37 | 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 | 0.533 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.13 | 2-Sided | 95 | -0.54 | 0.28 | 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 | 0.352 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.25 | 2-Sided | 95 | -0.79 | 0.28 | 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 | 0.573 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.15 | 2-Sided | 95 | -0.69 | 0.38 | 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 | 0.657 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.10 | 2-Sided | 95 | -0.54 | 0.34 | 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 |
| 0.242 |
p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| -0.15 |
| 2-Sided |
| 95 |
| -0.39 |
| 0.10 |
| 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 | 0.720 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.04 | 2-Sided | 95 | -0.17 | 0.24 | 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 | 0.235 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.16 | 2-Sided | 95 | -0.43 | 0.11 | 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 | 0.630 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.07 | 2-Sided | 95 | -0.34 | 0.20 | 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 | 0.393 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.10 | 2-Sided | 95 | -0.32 | 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 | 0.382 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.14 | 2-Sided | 95 | -0.46 | 0.18 | 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 | 0.995 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.00 | 2-Sided | 95 | -0.32 | 0.32 | 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 | 0.287 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.14 | 2-Sided | 95 | -0.41 | 0.12 | 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 |
| 0.324 |
p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| -0.34 |
| 2-Sided |
| 95 |
| -1.01 |
| 0.34 |
| 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 | 0.902 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | 0.03 | 2-Sided | 95 | -0.52 | 0.59 | 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 | 0.273 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.42 | 2-Sided | 95 | -1.17 | 0.33 | 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 | 0.616 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.19 | 2-Sided | 95 | -0.94 | 0.56 | 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 | 0.471 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.23 | 2-Sided | 95 | -0.85 | 0.39 | 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 | 0.356 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.40 | 2-Sided | 95 | -1.24 | 0.45 | 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 | 0.722 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.15 | 2-Sided | 95 | -1.00 | 0.69 | 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 | 0.493 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.24 | 2-Sided | 95 | -0.94 | 0.46 | 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 |
| 0.378 |
p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| -0.21 |
| 2-Sided |
| 95 |
| -0.69 |
| 0.26 |
| 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 | 0.762 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.06 | 2-Sided | 95 | -0.45 | 0.33 | 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 | 0.281 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.42 | 2-Sided | 95 | -1.17 | 0.34 | 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 | 0.582 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.21 | 2-Sided | 95 | -0.97 | 0.55 | 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 | 0.523 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.20 | 2-Sided | 95 | -0.83 | 0.42 | 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 |
| 0.489 |
p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| -0.32 |
| 2-Sided |
| 95 |
| -1.21 |
| 0.58 |
| 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 | 0.726 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.13 | 2-Sided | 95 | -0.88 | 0.61 | 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 | 0.320 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.70 | 2-Sided | 95 | -2.09 | 0.69 | 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 | 0.506 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.47 | 2-Sided | 95 | -1.86 | 0.92 | 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 | 0.691 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.23 | 2-Sided | 95 | -1.38 | 0.92 | 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 |
| 0.439 |
p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). |
| LS mean difference |
| -0.53 |
| 2-Sided |
| 95 |
| -1.87 |
| 0.82 |
| 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 | 0.733 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.19 | 2-Sided | 95 | -1.31 | 0.92 | 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 | 0.526 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.68 | 2-Sided | 95 | -2.80 | 1.43 | 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 | 0.624 | p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided). | LS mean difference | -0.44 | 2-Sided | 95 | -2.19 | 1.31 | 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 | 0.467 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -4.47 | 2-Sided | 95 | -17.61 | 8.68 | 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 | 0.164 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 7.55 | 2-Sided | 95 | -2.96 | 18.05 | 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 | 0.427 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -7.52 | 2-Sided | 95 | -25.96 | 10.92 | 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 | 0.537 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -5.66 | 2-Sided | 95 | -23.57 | 12.25 | 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 | 0.813 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.83 | 2-Sided | 95 | -16.88 | 13.22 | 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 | 0.455 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -5.50 | 2-Sided | 95 | -19.24 | 8.24 | 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 | 0.570 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -4.02 | 2-Sided | 95 | -17.63 | 9.59 | 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 | 0.792 | p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.65 | 2-Sided | 95 | -13.80 | 10.50 | 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 | 0.556 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -4.25 | 2-Sided | 95 | -17.82 | 9.33 | 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 | 0.689 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -2.77 | 2-Sided | 95 | -16.24 | 10.69 | 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 | 0.786 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.65 | 2-Sided | 95 | -13.45 | 10.14 | 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 | 0.612 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.34 | 2-Sided | 95 | -12.55 | 21.23 | 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 | 0.839 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 1.47 | 2-Sided | 95 | -12.60 | 15.55 | 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 | 0.130 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -13.20 | 2-Sided | 95 | -29.40 | 2.99 | 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 | 0.331 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -7.83 | 2-Sided | 95 | -23.39 | 7.73 | 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 | 0.450 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -5.50 | 2-Sided | 95 | -19.59 | 8.59 | 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 | 0.556 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -4.25 | 2-Sided | 95 | -17.82 | 9.33 | 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 | 0.689 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -2.77 | 2-Sided | 95 | -16.24 | 10.69 | 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 | 0.786 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.65 | 2-Sided | 95 | -13.45 | 10.14 | 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 | 0.556 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -4.25 | 2-Sided | 95 | -17.82 | 9.33 | 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 | 0.689 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -2.77 | 2-Sided | 95 | -16.24 | 10.69 | 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 | 0.786 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.65 | 2-Sided | 95 | -13.45 | 10.14 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 3 hours |
|
| 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 | 0.623 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -1.21 | 2-Sided | 95 | -6.62 | 4.20 | 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 | 0.094 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.10 | 2-Sided | 95 | -0.90 | 11.11 | 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 | 0.565 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 4.43 | 2-Sided | 95 | -10.43 | 19.29 | 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 | 0.765 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -2.09 | 2-Sided | 95 | -16.15 | 11.97 | 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 | 0.288 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 6.47 | 2-Sided | 95 | -5.43 | 18.37 | 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 | 0.928 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -0.87 | 2-Sided | 95 | -20.00 | 18.27 | 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 | 0.495 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | -6.40 | 2-Sided | 95 | -25.14 | 12.33 | 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 | 0.477 | p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided). | Difference in proportion | 5.46 | 2-Sided | 95 | -9.66 | 20.59 | No | Superiority or Other |