Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain

Study Overview
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Brief Summary
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To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.

Official Title
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A Randomized, Double-Blind, Multicenter, Comparative Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In The Treatment Of Acute Pain After Oral Surgery Lateral Mandibular Impacted Third Molar Tooth Extraction

Conditions
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Pain

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initial dose: 20 to 64 years Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting Patients with pain that meets both of the following criteria Pain intensity (4-categorical): moderate pain or severe pain Pain intensity (VAS): 45.0 mm or more Additional dose: Patients with pain that corresponds to 4. Agree or 5. Strongly agree as the answer to the question about the pain intensity during the period from 5 hours to 12 hours post-initial dose of the study drug Exclusion Criteria: Patients with acute inflammatory findings in the oral cavity necessitating treatment Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Celecoxib 400mg<br> | Drug: Celecoxib<br>* Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with moderate pain or severe painrated as 45.0 mm or more on the VAS<br>|
| Experimental: Celecoxib 200mg<br> | Drug: Celecoxib<br>* Additional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Rate (Percentage) of Patient's Impression | Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent,  Good, Fair and Poor. Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100. | 2 hours post-additional dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Each Pain Intensity (PI) With 4 Categories | Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain. | 2 hours after additional dose | 
| Pain Intensity Measured by Visual Analog Scale (VAS) | The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain. | 2 hours post-additional dose | 
| Differences in Pain Intensity (PI) Measured by VAS Among Participants | The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score. | Pre-additional dose (baseline) and 2 hours post-additional dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction