Study Comparing the Efficacy of Two Ibuprofen Formulations

Study Overview
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Brief Summary
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This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

Official Title
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A Study Comparing the Efficacy of Two Ibuprofen Formulations

Conditions
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Pain

Intervention / Treatment
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* Drug: placebo
* Drug: ibuprofen Formulation 1
* Drug: ibuprofen Formulation 2


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Outpatients with post-operative pain following surgical extraction of third molars, examined by the attending dentist or physician and medically cleared to participate in the study, in general good health and have no contraindications to the study or rescue medication. Exclusions criteria: any serious medical condition, acute localized dental infection at the time of surgery , females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* 2 placebo gels capsules delivered as a single dose.<br>|
| Active Comparator: 2<br> | Drug: ibuprofen Formulation 1<br>* 2 marketed ibuprofen gels<br>|
| Active Comparator: 3<br> | Drug: ibuprofen Formulation 2<br>* 2 marketed ibuprofen gels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental pain analgesia