Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
- Registration Number
- NCT01062113
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Celecoxib 200mg Celecoxib - Celecoxib 400mg Celecoxib -
- 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.
Trial Locations
- Locations (22)
Kumamoto Medical Center
🇯🇵Kumamoto-shi, Kumamoto, Japan
Jyuzen General Hospital
🇯🇵Niihama-shi, Ehime, Japan
Maruko Central General Hospital
🇯🇵Ueda-shi, Nagano, Japan
Nagano National Hospital
🇯🇵Ueda-shi, Nagano, Japan
Kyushu Dental College Hospital
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Bishinkai Medical Corporation Health Park Clinic
🇯🇵Takasaki-shi, Gunma, Japan
Tokai University Hospital
🇯🇵Isehara-shi, Kanagawa, Japan
Osaka Prefectural General Medical Center
🇯🇵Osaka-shi, Osaka, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Showa University Dental Hospital
🇯🇵Ota-ku, Tokyo, Japan
Tochigi National Hospital
🇯🇵Utsunomiya-shi, Tochigi, Japan
Kanto Medical Center NTT EC
🇯🇵Shinagawa-ku, Tokyo, Japan
Japan Red Cross Musashino Hospital
🇯🇵Musashino-shi, Tokyo, Japan
The Nippon Dental University Niigata Hospital
🇯🇵Niigata-shi, Niigata, Japan
Kure Kyosai Hospital
🇯🇵Kure-shi, Hiroshima, Japan
Kagawa University Faculty of Medicine University Hospital
🇯🇵Kita-gun, Kagawa, Japan
Sendai Medical Center
🇯🇵Sendai-shi, Miyagi, Japan
Kanazawa Medical Center
🇯🇵Kanazawa-shi, Ishikawa, Japan
Osaka Dental University Hospital
🇯🇵Osaka-shi, Osaka, Japan
Meikai University Hospital
🇯🇵Sakado-shi, Saitama, Japan
Shizuoka Medical Center
🇯🇵Sunto-gun, Shizuoka, Japan
Tokai University Hachioji Hospital
🇯🇵Hachiouji-shi, Tokyo, Japan