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| ID | Type | Description | Link |
|---|---|---|---|
| AK-10-13 | Other Identifier | Alias Study Number |
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The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen 600 mg extended release | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 600 mg ER | Drug | One 600 mg caplet dosed at 0, 12, 24 and 36 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12) | SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals [=] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy. | Baseline to 12 hours |
| Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose | SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy. | 8 to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference (SPID) Scores | SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity. |
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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 |
|---|---|---|---|---|---|---|
| Central Texas Oral Surgery Associates | Austin | Texas | 78705 | United States | ||
| Premier Research |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
| FG001 | Ibuprofen | Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
| BG001 | Ibuprofen | Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
| 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 and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12) | SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals [=] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy. | Intent-to-treat (ITT) population: Randomized participants with at least moderate baseline pain (score 2 on the pain severity rating [PSR] scale) confirmed by a score of at least 50 millimeter (mm) on the 100-mm visual analog scale (VAS)-PSR, within approximately 5 hours after surgery, provided a baseline assessment, and received study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 hours |
Not provided
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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 | Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | One placebo caplet dosed at times 0, 12, 24 and 36 hours |
|
| 0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours |
| Time to First Dose of Rescue Medication After First Dose of Study Drug | During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded. | Baseline to 12 hours |
| Percentage of Participants Taking Rescue Medication | Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval. | Baseline to 48 hours |
| Pain Relief (PR) Scores | A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief. | 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours |
| Pain Intensity Difference (PID) Scores | For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity). | 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours |
| Pain Relief Combined With Pain Intensity (PRID) Scores | PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity. | 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours |
| Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best). | 0-12 hours, 8-12 hours |
| Number of Doses of Rescue Medication Used | 0-12, 12-24, 24-36, 36-48, 0-48 hours |
| Time to Confirmed First Perceptible Relief | The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling. | Baseline to 12 hours |
| Time to Meaningful Relief | Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant. | Baseline to 12 hours |
| Participant Global Evaluation Score | Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. | 24 and 48 hours |
| Austin |
| Texas |
| 78705 |
| United States |
| Vomited within 4 hours of dosing |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Severity | A 4-point categorical pain severity rating scale was used to rate the severity of baseline pain in response to the query " My starting pain is:" Responses ranged and were scored as follows: None (0), Mild (1), Moderate (2), Severe (3). A baseline pain intensity score of at least moderate was required for study enrollment. | Number | participants |
|
| Pain Intensity | A 100-millimeter (mm) visual analog scale-pain severity rating (VAS-PSR) rated intensity of baseline pain. Participants were asked to "Draw a single vertical line on the scale that shows how much pain you have at this time." Scores on this 100-mm linear scale measured to nearest millimeter from left. Zero on the scale represented no pain and 100 represented the worst pain. Score of at least 50 mm required for enrolment. | Mean | Standard Deviation | millimeter |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Placebo | Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
| OG001 | Ibuprofen | Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours |
|
|
|
| Primary | Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose | SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy. | ITT population | Posted | Mean | Standard Deviation | units on a scale | 8 to 12 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Intensity Difference (SPID) Scores | SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity. | ITT population | Posted | Mean | Standard Deviation | units on a scale | 0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours |
|
|
|
|
| Secondary | Time to First Dose of Rescue Medication After First Dose of Study Drug | During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded. | ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures". | Posted | Median | 95% Confidence Interval | hours | Baseline to 12 hours |
|
|
|
|
| Secondary | Percentage of Participants Taking Rescue Medication | Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval. | ITT population | Posted | Number | percentage of participants | Baseline to 48 hours |
|
|
|
|
| Secondary | Pain Relief (PR) Scores | A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief. | ITT population | Posted | Mean | Standard Deviation | units on a scale | 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours |
|
|
|
|
| Secondary | Pain Intensity Difference (PID) Scores | For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity). | ITT population | Posted | Mean | Standard Deviation | units on a scale | 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours |
|
|
|
|
| Secondary | Pain Relief Combined With Pain Intensity (PRID) Scores | PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity. | ITT population | Posted | Mean | Standard Deviation | units on a scale | 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Scores (TOTPAR) | TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best). | ITT population | Posted | Mean | Standard Deviation | units on a scale | 0-12 hours, 8-12 hours |
|
|
|
|
| Secondary | Number of Doses of Rescue Medication Used | ITT population | Posted | Mean | Standard Deviation | doses | 0-12, 12-24, 24-36, 36-48, 0-48 hours |
|
|
|
|
| Secondary | Time to Confirmed First Perceptible Relief | The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling. | ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures". | Posted | Median | 95% Confidence Interval | minutes | Baseline to 12 hours |
|
|
|
| Secondary | Time to Meaningful Relief | Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant. | ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures". | Posted | Median | 95% Confidence Interval | minutes | Baseline to 12 hours |
|
|
|
| Secondary | Participant Global Evaluation Score | Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. | ITT population | Posted | Mean | Standard Deviation | units on a scale | 24 and 48 hours |
|
|
|
|
| 0 |
| 52 |
| 23 |
| 52 |
| EG001 | Ibuprofen | Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours | 0 | 54 | 8 | 54 |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Flushing | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin burning sensation | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
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.
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| SPID 12-24 |
|
| SPID 20-24 |
|
| SPID 0-24 |
|
| SPID 24-36 |
|
| SPID 32-36 |
|
| SPID 36-48 |
|
| SPID 44-48 |
|
| SPID 24-48 |
|
| ANOVA |
| <0.001 |
p-Value from ANOVA model with treatment, baseline PSR, and gender terms. |
| Least-squares means |
| 3.15 |
| 2-Sided |
| 95 |
| 1.45 |
| 4.85 |
| Superiority |
| For SPID 12-24. | ANOVA | <0.001 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 6.56 | 2-Sided | 95 | 2.84 | 10.27 | Superiority |
| For SPID 20-24. | ANOVA | 0.091 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 2.02 | 2-Sided | 95 | -0.33 | 4.37 | Superiority |
| For SPID 0-24. | ANOVA | <0.001 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 14.95 | 2-Sided | 95 | 9.12 | 20.79 | Superiority |
| For SPID 24-36. | ANOVA | 0.010 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 5.87 | 2-Sided | 95 | 1.42 | 10.33 | Superiority |
| For SPID 32-36. | ANOVA | 0.004 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 3.48 | 2-Sided | 95 | 1.13 | 5.83 | Superiority |
| For SPID 36-48. | ANOVA | 0.006 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 6.09 | 2-Sided | 95 | 1.82 | 10.36 | Superiority |
| For SPID 44-48. | ANOVA | 0.042 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 2.41 | 2-Sided | 95 | 0.09 | 4.73 | Superiority |
| For SPID 24-48. | ANOVA | 0.004 | p-Value from ANOVA model with treatment, baseline PSR, and gender terms. | Least-squares means | 10.97 | 2-Sided | 95 | 3.49 | 18.45 | Superiority |
| Third dosing interval (24 to 36 hours) |
|
| Fourth dosing interval (36 to 48 hours) |
|
| Overall during the study (0 to 48 hours) |
|
During the second dosing interval (12 to 24 hours).
| Cochran-Mantel-Haenszel |
| <0.001 |
p-Values from the CMH test, controlling for baseline PSR and gender. |
| Treatment Difference |
| -25.53 |
| 95 |
| -39.78 |
| -11.28 |
| Superiority |
| During the third dosing interval (24 to 36 hours). | Cochran-Mantel-Haenszel | 0.002 | p-Values from the CMH test, controlling for baseline PSR and gender. | Treatment Difference | -24.05 | 95 | -38.93 | -9.18 | Superiority |
| During the fourth dosing interval (36 to 48 hours). | Cochran-Mantel-Haenszel | 0.035 | p-Values from the CMH test, controlling for baseline PSR and gender. | Treatment Difference | -13.60 | 95 | -26.41 | -0.79 | Superiority |
| During the study overall (0 to 48 hours). | Cochran-Mantel-Haenszel | <0.001 | p-Values from the CMH test, controlling for baseline PSR and gender. | Treatment Difference | -48.01 | 95 | -64.42 | -31.60 | Superiority |
| Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours) | Andersen-Gill (AG) | 0.011 | Cox proportional hazard models | 0.086 | 2-Sided | 95 | 0.01 | 0.57 | Superiority |
| 1.5 hours |
|
| 2 hours |
|
| 4 hours |
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| ANOVA |
| <0.001 |
p-Values from ANOVA model with treatment, baseline PSR, and gender terms. |
| Least squares means |
| 1.53 |
| 95 |
| 1.11 |
| 1.94 |
| Superiority |
| Ibuprofen versus placebo at 1.5 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 2.00 | 95 | 1.56 | 2.44 | Superiority |
| Ibuprofen versus placebo at 2 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 2.29 | 95 | 1.86 | 2.73 | Superiority |
| Ibuprofen versus placebo at 4 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 2.18 | 95 | 1.69 | 2.68 | Superiority |
| Ibuprofen versus placebo at 6 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.92 | 95 | 0.46 | 1.38 | Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model. | Superiority |
| Ibuprofen versus placebo at 8 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 1.04 | 95 | 0.54 | 1.54 | Superiority |
| Ibuprofen versus placebo at 10 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 1.10 | 95 | 0.59 | 1.60 | Superiority |
| Ibuprofen versus placebo at 12 hours. | ANOVA | 0.052 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.50 | 95 | -0.00 | 1.01 | Superiority |
| 1.5 hours |
|
| 2 hours |
|
| 4 hours |
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| 16 hours |
|
| 20 hours |
|
| 24 hours |
|
| 28 hours |
|
| 32 hours |
|
| 36 hours |
|
| 40 hours |
|
| 44 hours |
|
| 48 hours |
|
| ANOVA |
| <0.001 |
p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. |
| Least squares means |
| 0.90 |
| 95 |
| 0.63 |
| 1.18 |
| Superiority |
| Ibuprofen versus placebo at 1.5 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 1.22 | 95 | 0.91 | 1.52 | Superiority |
| Ibuprofen versus placebo at 2 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 1.40 | 95 | 1.10 | 1.71 | Superiority |
| Ibuprofen versus placebo at 4 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 1.32 | 95 | 0.97 | 1.67 | Superiority |
| Ibuprofen versus placebo at 6 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 0.61 | 95 | 0.30 | 0.91 | Superiority |
| Ibuprofen versus placebo at 8 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 0.64 | 95 | 0.31 | 0.97 | Superiority |
| Ibuprofen versus placebo at 10 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 0.66 | 95 | 0.36 | 0.97 | Superiority |
| Ibuprofen versus placebo at 12 hours. | ANOVA | 0.089 | p-Values from ANOVA model with treatment, baseline pain severity, and gender terms. | Least squares means | 0.27 | 95 | -0.04 | 0.59 | Superiority |
| Ibuprofen versus placebo at 16 hours. | ANOVA | <0.001 | Ibuprofen versus placebo at 0.5 hours. | Least squares means | 1.00 | 95 | 0.70 | 1.29 | Superiority |
| Ibuprofen versus placebo at 20 hours. | ANOVA | 0.004 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.47 | 95 | 0.15 | 0.78 | Superiority |
| Ibuprofen versus placebo at 24 hours. | ANOVA | 0.821 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.04 | 95 | -0.28 | 0.35 | Superiority |
| Ibuprofen versus placebo at 28 hours. | ANOVA | 0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.56 | 95 | 0.23 | 0.90 | Superiority |
| Ibuprofen versus placebo at 32 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.62 | 95 | 0.30 | 0.94 | Superiority |
| Ibuprofen versus placebo at 36 hours. | ANOVA | 0.127 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.25 | 95 | -0.07 | 0.57 | Superiority |
| Ibuprofen versus placebo at 40 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.67 | 95 | 0.35 | 1.00 | Superiority |
| Ibuprofen versus placebo at 44 hours. | ANOVA | 0.036 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.34 | 95 | 0.02 | 0.67 | Superiority |
| Ibuprofen versus placebo at 48 hours. | ANOVA | 0.091 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.26 | 95 | -0.04 | 0.56 | Superiority |
| 1.5 hours |
|
| 2 hours |
|
| 4 hours |
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 12 hours |
|
| ANOVA |
| <0.001 |
p-Values from ANOVA model with treatment, baseline PSR, and gender terms. |
| Least squares means |
| 2.43 |
| 95 |
| 1.77 |
| 3.09 |
| Superiority |
| Ibuprofen versus placebo at 1.5 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 3.22 | 95 | 2.49 | 3.95 | Superiority |
| Ibuprofen versus placebo at 2 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 3.70 | 95 | 2.98 | 4.42 | Superiority |
| Ibuprofen versus placebo at 4 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 3.50 | 95 | 2.67 | 4.33 | Superiority |
| Ibuprofen versus placebo at 6 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 1.53 | 95 | 0.79 | 2.27 | Superiority |
| Ibuprofen versus placebo at 8 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 1.67 | 95 | 0.87 | 2.48 | Superiority |
| Ibuprofen versus placebo at 10 hours. | ANOVA | <0.001 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 1.76 | 95 | 0.97 | 2.54 | Superiority |
| Ibuprofen versus placebo at 12 hours. | ANOVA | 0.056 | p-Values from ANOVA model with treatment, baseline PSR, and gender terms. | Least squares means | 0.78 | 95 | -0.02 | 1.58 | Superiority |
Ibuprofen versus placebo from 8 to 12 hours.
| ANOVA |
| <0.001 |
p-Value from ANOVA model with treatment, baseline pain severity, and gender terms. |
| Least squares means |
| 5.27 |
| 2-Sided |
| 95 |
| 2.57 |
| 7.98 |
| Superiority |
| Third dosing interval (24-36 hours) |
|
| Fourth dosing interval (36-48 hours) |
|
| Overall during the study (0-48 hours) |
|
For the second dosing interval.
| Cochran-Mantel-Haenszel |
| <0.001 |
Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors. |
| CMH-adjusted proportions |
| -0.72 |
| 2-Sided |
| 95 |
| -1.05 |
| -0.40 |
| Superiority |
| For the third dosing interval. | Cochran-Mantel-Haenszel | 0.002 | p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender. | CMH-adjusted proportions | -0.48 | 2-Sided | 95 | -0.90 | -0.06 | Superiority |
| For the fourth dosing interval. | Cochran-Mantel-Haenszel | 0.021 | p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender. | CMH-adjusted proportion | -0.68 | 2-Sided | 95 | -1.02 | -0.35 | Superiority |
| For the overall study duration. | Cochran-Mantel-Haenszel | <0.001 | p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender. | CMH-adjusted proportion | -0.70 | 2-Sided | 95 | -0.89 | -0.51 | Superiority |
Ibuprofen versus placebo at 48 hours
| Cochran-Mantel-Haenszel |
p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender. |
| <0.001 |
| Gamma statistic |
| 0.79 |
| 2-Sided |
| 95 |
| 0.66 |
| 0.92 |
| Superiority |