Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
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
1 other identifier
interventional
255
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Apr 2010
Shorter than P25 for phase_2 pain
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
November 19, 2012
CompletedFebruary 2, 2021
January 1, 2021
4 months
February 2, 2010
August 1, 2011
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Participants in Each Pain Intensity (PI) With 4 Categories
2 hours after additional dose
Pain Intensity Measured by Visual Analog Scale (VAS)
2 hours post-additional dose
Differences in Pain Intensity (PI) Measured by VAS Among Participants
Pre-additional dose (baseline) and 2 hours post-additional dose
Study Arms (3)
Celecoxib 400mg
EXPERIMENTALCelecoxib 200mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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
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
You may qualify if:
- Initial dose:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Related Publications (1)
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.
PMID: 22284900DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer Clinical Trials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 4, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 2, 2021
Results First Posted
November 19, 2012
Record last verified: 2021-01