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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01062113
First received: February 2, 2010
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Celecoxib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Efficacy Rate (Percentage) of Patient's Impression [ Time Frame: 2 hours post-additional dose ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Number of Participants in Each Pain Intensity (PI) With 4 Categories [ Time Frame: 2 hours after additional dose ] [ Designated as safety issue: No ]
    Pain intensity was entered in the patient diary on the following categories: "No pain", "Mild pain", "Moderate pain" and "Severe pain".

  • Pain Intensity Measured by Visual Analog Scale (VAS) [ Time Frame: 2 hours post-additional dose ] [ Designated as safety issue: No ]
    The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.

  • Differences in Pain Intensity (PI) Measured by VAS Among Participants [ Time Frame: Pre-additional dose (baseline) and 2 hours post-additional dose ] [ Designated as safety issue: No ]
    The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.


Enrollment: 255
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Celecoxib 200mg 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
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062113

Locations
Japan
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-shi, Ishikawa, Japan
Kagawa University Faculty of Medicine University Hospital
Kita-gun, Kagawa, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Kumamoto Medical Center
Kumamoto-shi, Kumamoto, Japan
Sendai Medical Center
Sendai-shi, Miyagi, Japan
Nagano National Hospital
Ueda-shi, Nagano, Japan
Maruko Central General Hospital
Ueda-shi, Nagano, Japan
The Nippon Dental University Niigata Hospital
Niigata-shi, Niigata, Japan
Osaka Prefectural General Medical Center
Osaka-shi, Osaka, Japan
Osaka Dental University Hospital
Osaka-shi, Osaka, Japan
Meikai University Hospital
Sakado-shi, Saitama, Japan
Shizuoka Medical Center
Sunto-gun, Shizuoka, Japan
Tochigi National Hospital
Utsunomiya-shi, Tochigi, Japan
Tokai University Hachioji Hospital
Hachiouji-shi, Tokyo, Japan
Japan Red Cross Musashino Hospital
Musashino-shi, Tokyo, Japan
Showa University Dental Hospital
Ota-ku, Tokyo, Japan
Kanto Medical Center NTT EC
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01062113     History of Changes
Other Study ID Numbers: A3191200
Study First Received: February 2, 2010
Results First Received: August 1, 2011
Last Updated: October 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 28, 2014