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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Celecoxib; Drug: Celecoxib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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
EXPERIMENTAL: Celecoxib 400mg	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; Drug: 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
EXPERIMENTAL: Celecoxib 200mg	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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (ESTIMATE): February 4, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: A3191200