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”

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.

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • Initial dose: Celecoxib 400mg (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: Celecoxib 200mg (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
• Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Celecoxib
• Placebo Comparator: Placebo

Primary Measures

• Patient's impression (rate of the patient's assessment as "it worked well" and "it worked")
  • Time Frame: 1 day
    Safety Issue?: No

Secondary Measures

• Pain intensity (4 categorical)
  • Time Frame: 2 days
    Safety Issue?: No
• Pain intensity (VAS)
  • Time Frame: 2 days
    Safety Issue?: No
• Safety (adverse event, physical examination, lab tests, urinary pregnancy test, standard 12-lead ECG, blood pressure, pulse rate)
  • Time Frame: 2 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01062113

Study ID Number: A3191200

ClinicalTrials.gov Identifier: NCT01062113

Health Authority: Japan: Ministry of Health, Labor and Welfare

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