Clinical trial NCT01062113: Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 255
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Rate (Percentage) of Patient's Impression
timeFrame: 2 hours post-additional dose
Secondary outcomes:
measure: Number of Participants in Each Pain Intensity (PI) With 4 Categories
timeFrame: 2 hours after additional dose
measure: Pain Intensity Measured by Visual Analog Scale (VAS)
timeFrame: 2 hours post-additional dose
measure: Differences in Pain Intensity (PI) Measured by VAS Among Participants
timeFrame: Pre-additional dose (baseline) and 2 hours post-additional dose
Other outcomes:
Locations:
city: Niihama-shi
country: Japan
facility: Jyuzen General Hospital
state: Ehime
city: Kitakyusyu-shi
country: Japan
facility: Kyushu Dental College Hospital
state: Fukuoka
city: Takasaki-shi
country: Japan
facility: Bishinkai Medical Corporation Health Park Clinic
state: Gunma
city: Kure-shi
country: Japan
facility: Kure Kyosai Hospital
state: Hiroshima
city: Kanazawa-shi
country: Japan
facility: Kanazawa Medical Center
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Faculty of Medicine University Hospital
state: Kagawa
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto Medical Center
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Sendai Medical Center
state: Miyagi
city: Ueda-shi
country: Japan
facility: Maruko Central General Hospital
state: Nagano
city: Ueda-shi
country: Japan
facility: Nagano National Hospital
state: Nagano
city: Niigata-shi
country: Japan
facility: The Nippon Dental University Niigata Hospital
state: Niigata
city: Osaka-shi
country: Japan
facility: Osaka Dental University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Prefectural General Medical Center
state: Osaka
city: Sakado-shi
country: Japan
facility: Meikai University Hospital
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Medical Center
state: Shizuoka
city: Utsunomiya-shi
country: Japan
facility: Tochigi National Hospital
state: Tochigi
city: Hachiouji-shi
country: Japan
facility: Tokai University Hachioji Hospital
state: Tokyo
city: Musashino-shi
country: Japan
facility: Japan Red Cross Musashino Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Showa University Dental Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kanto Medical Center NTT EC
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Saito K, Kaneko A, Machii K, Ohta H, Ohkura M, Suzuki M. Efficacy and safety of additional 200-mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double-blind, placebo-controlled, phase II study in Japan. Clin Ther. 2012 Feb;34(2):314-28. doi: 10.1016/j.clinthera.2012.01.004. Epub 2012 Jan 28.