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This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 2 placebo gels capsules delivered as a single dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Meaningful Pain Relief | Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better. | 0-6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Difference (PID) Scores at Each Individual Time Points | PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement. | 0-6 hours |
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Inclusion criteria :
Exclusions criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salt Lake City | Utah | 84124 | United States |
During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient's eligibility. Surgery occurred within 14 days of the screening visit.
Patients were recruited in the United States from August 2008 to October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery |
| FG001 | Ibuprofen Formulation 1 | 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery |
| FG002 | Ibuprofen Formulation 2 | 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery |
| BG001 | Ibuprofen Formulation 1 | 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery |
| 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 to Meaningful Pain Relief | Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better. | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes. | Posted | Oct 2009 | Median | 95% Confidence Interval | minutes | 0-6 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 | Placebo | 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ibuprofen Formulation 1 |
| Drug |
2 marketed ibuprofen gels |
|
| ibuprofen Formulation 2 | Drug | 2 marketed ibuprofen gels |
|
| Pain Relief (PR) Scores at Individual Time Points | Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken. | 0-6 hours |
| Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best). | 0-2 and 0-6 hours |
| Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best). | 0-6 hours |
| Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best). | 0-2 and 0-6 hours |
| Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best) | 0-2 and 0-6 hours |
| Time to First Perceptible Relief | The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief. | 0-6 hours |
| BG002 | Ibuprofen Formulation 2 | 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Ibuprofen Formulation 1 | 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery |
| OG002 | Ibuprofen Formulation 2 | 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery |
|
|
|
| Secondary | Pain Intensity Difference (PID) Scores at Each Individual Time Points | PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement. | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). | Posted | Oct 2009 | Mean | Standard Deviation | units on scale | 0-6 hours |
|
|
|
|
| Secondary | Pain Relief (PR) Scores at Individual Time Points | Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken. | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). | Posted | Oct 2009 | Mean | Standard Deviation | units on scale | 0-6 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best). | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). | Posted | Oct 2009 | Mean | Standard Deviation | units on scale | 0-2 and 0-6 hours |
|
|
|
|
| Secondary | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best). | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). | Posted | Oct 2009 | Mean | Standard Deviation | units on scale | 0-6 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best). | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). | Posted | Oct 2009 | Mean | Standard Deviation | units on scale | 0-2 and 0-6 hours |
|
|
|
|
| Secondary | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best) | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). | Posted | Oct 2009 | Mean | Standard Deviation | units on scale | 0-2 and 0-6 hours |
|
|
|
|
| Secondary | Time to First Perceptible Relief | The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief. | All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes. | Posted | Oct 2009 | Median | 95% Confidence Interval | minutes | 0-6 hours |
|
|
|
|
| 0 |
| 33 |
| 13 |
| 33 |
| EG001 | Ibuprofen Formulation 1 | 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery | 0 | 88 | 2 | 88 |
| EG002 | Ibuprofen Formulation 2 | 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery | 0 | 90 | 7 | 90 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Dry socket | Infections and infestations | Non-systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | Non-systematic Assessment |
|
The PI agreed to allow the sponsor 30 days to review and approve abstracts and 60 days to review and approve manuscripts prior to submission to protect against disclosure of confidential information.
|
| 45 minutes |
|
| 60 minutes |
|
| 90 minutes |
|
| 120 minutes |
|
| 180 minutes |
|
| 240 minutes |
|
| 300 minutes |
|
| 360 minutes |
|
| ANOVA |
With treatment, baseline Pain Severity Rating (PSR), and gender terms. |
| <0.001 |
| No |
| Superiority or Other |
|
| 45 minutes |
|
| 60 minutes |
|
| 90 minutes |
|
| 120 minutes |
|
| 180 minutes |
|
| 240 minutes |
|
| 300 minutes |
|
| 360 minutes |
|
| ANOVA |
With treatment, baseline Pain Severity Rating (PSR), and gender terms. |
| <0.001 |
| No |
| Superiority or Other |
|
|
| 45 minutes |
|
| 60 minutes |
|
| 90 minutes |
|
| 120 minutes |
|
| 180 minutes |
|
| 240 minutes |
|
| 300 minutes |
|
| 360 minutes |
|
| ANOVA |
Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms. |
| <0.001 |
| No |
| Superiority or Other |
|
|