Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
NCT ID: NCT01062113
Last Updated: 2021-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
255 participants
INTERVENTIONAL
2010-04-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Celecoxib 400mg
Celecoxib
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 pain"rated as 45.0 mm or more on the VAS
Celecoxib 200mg
Celecoxib
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
Placebo
Placebo
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
Interventions
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Celecoxib
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 pain"rated as 45.0 mm or more on the VAS
Celecoxib
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
Placebo
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
Eligibility Criteria
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Inclusion Criteria
* 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 who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction
20 Years
64 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Jyuzen General Hospital
Niihama-shi, Ehime, Japan
Kyushu Dental College Hospital
Kitakyusyu-shi, Fukuoka, Japan
Bishinkai Medical Corporation Health Park Clinic
Takasaki-shi, Gunma, Japan
Kure Kyosai Hospital
Kure-shi, Hiroshima, Japan
Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
Kagawa University Faculty of Medicine University Hospital
Kita-gun, Kagawa-ken, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Kumamoto Medical Center
Kumamoto, Kumamoto, Japan
Sendai Medical Center
Sendai, Miyagi, Japan
Maruko Central General Hospital
Ueda-shi, Nagano, Japan
Nagano National Hospital
Ueda-shi, Nagano, Japan
The Nippon Dental University Niigata Hospital
Niigata, Niigata, Japan
Osaka Dental University Hospital
Osaka, Osaka, Japan
Osaka Prefectural General Medical Center
Osaka, Osaka, Japan
Meikai University Hospital
Sakado-shi, Saitama, Japan
Shizuoka Medical Center
Sunto-gun, Shizuoka, Japan
Tochigi National Hospital
Utsunomiya, Tochigi, Japan
Tokai University Hachioji Hospital
Hachiouji-shi, Tokyo, Japan
Japan Red Cross Musashino Hospital
Musashino-shi, Tokyo, Japan
Showa University Dental Hospital
Ōta-ku, Tokyo, Japan
Kanto Medical Center NTT EC
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191200
Identifier Type: -
Identifier Source: org_study_id
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