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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062113
• Other study ID #: A3191200
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: August 2010

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

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

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	Tokai University Hachioji Hospital	Hachiouji-shi	Tokyo
Japan	Tokai University Hospital	Isehara-shi	Kanagawa
Japan	Kanazawa Medical Center	Kanazawa-shi	Ishikawa
Japan	Kagawa University Faculty of Medicine University Hospital	Kita-gun	Kagawa
Japan	Kyushu Dental College Hospital	Kitakyusyu-shi	Fukuoka
Japan	Kumamoto Medical Center	Kumamoto-shi	Kumamoto
Japan	Kure Kyosai Hospital	Kure-shi	Hiroshima
Japan	Japan Red Cross Musashino Hospital	Musashino-shi	Tokyo
Japan	The Nippon Dental University Niigata Hospital	Niigata-shi	Niigata
Japan	Jyuzen General Hospital	Niihama-shi	Ehime
Japan	Osaka Dental University Hospital	Osaka-shi	Osaka
Japan	Osaka Prefectural General Medical Center	Osaka-shi	Osaka
Japan	Showa University Dental Hospital	Ota-ku	Tokyo
Japan	Meikai University Hospital	Sakado-shi	Saitama
Japan	Sendai Medical Center	Sendai-shi	Miyagi
Japan	Kanto Medical Center NTT EC	Shinagawa-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Shizuoka Medical Center	Sunto-gun	Shizuoka
Japan	Bishinkai Medical Corporation Health Park Clinic	Takasaki-shi	Gunma
Japan	Maruko Central General Hospital	Ueda-shi	Nagano
Japan	Nagano National Hospital	Ueda-shi	Nagano
Japan	Tochigi National Hospital	Utsunomiya-shi	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

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