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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Efficacy Rate (Percentage) of Patient's Impression	2 hours post-additional dose	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.

Secondary Outcome Measures

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

Locations (22): Jyuzen General Hospital
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Niihama-shi, Ehime, Japan
Kyushu Dental College Hospital
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Kitakyusyu-shi, Fukuoka, Japan
Bishinkai Medical Corporation Health Park Clinic
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Takasaki-shi, Gunma, Japan
Kure Kyosai Hospital
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Kure-shi, Hiroshima, Japan
Kanazawa Medical Center
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Kanazawa-shi, Ishikawa, Japan
Kagawa University Faculty of Medicine University Hospital
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Kita-gun, Kagawa, Japan
Tokai University Hospital
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Isehara-shi, Kanagawa, Japan
Kumamoto Medical Center
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Kumamoto-shi, Kumamoto, Japan
Sendai Medical Center
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Sendai-shi, Miyagi, Japan
Maruko Central General Hospital
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Ueda-shi, Nagano, Japan
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Jyuzen General Hospital
🇯🇵Niihama-shi, Ehime, Japan