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

Primary Purpose

Pain

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Celecoxib
Celecoxib
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jyuzen General Hospital
  • Kyushu Dental College Hospital
  • Bishinkai Medical Corporation Health Park Clinic
  • Kure Kyosai Hospital
  • Kanazawa Medical Center
  • Kagawa University Faculty of Medicine University Hospital
  • Tokai University Hospital
  • Kumamoto Medical Center
  • Sendai Medical Center
  • Maruko Central General Hospital
  • Nagano National Hospital
  • The Nippon Dental University Niigata Hospital
  • Osaka Dental University Hospital
  • Osaka Prefectural General Medical Center
  • Meikai University Hospital
  • Shizuoka Medical Center
  • Tochigi National Hospital
  • Tokai University Hachioji Hospital
  • Japan Red Cross Musashino Hospital
  • Showa University Dental Hospital
  • Kanto Medical Center NTT EC
  • Tokyo Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Celecoxib 400mg

Celecoxib 200mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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.
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.

Full Information

First Posted
February 2, 2010
Last Updated
January 29, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01062113
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib 400mg
Arm Type
Experimental
Arm Title
Celecoxib 200mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy Rate (Percentage) of Patient's Impression
Description
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.
Time Frame
2 hours post-additional dose
Secondary Outcome Measure Information:
Title
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Description
Pain intensity was entered in the patient diary on the following categories: "No pain", "Mild pain", "Moderate pain" and "Severe pain".
Time Frame
2 hours after additional dose
Title
Pain Intensity Measured by Visual Analog Scale (VAS)
Description
The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.
Time Frame
2 hours post-additional dose
Title
Differences in Pain Intensity (PI) Measured by VAS Among Participants
Description
The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.
Time Frame
Pre-additional dose (baseline) and 2 hours post-additional dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Jyuzen General Hospital
City
Niihama-shi
State/Province
Ehime
Country
Japan
Facility Name
Kyushu Dental College Hospital
City
Kitakyusyu-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Bishinkai Medical Corporation Health Park Clinic
City
Takasaki-shi
State/Province
Gunma
Country
Japan
Facility Name
Kure Kyosai Hospital
City
Kure-shi
State/Province
Hiroshima
Country
Japan
Facility Name
Kanazawa Medical Center
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
Facility Name
Kagawa University Faculty of Medicine University Hospital
City
Kita-gun
State/Province
Kagawa
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Kumamoto Medical Center
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
Facility Name
Sendai Medical Center
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Maruko Central General Hospital
City
Ueda-shi
State/Province
Nagano
Country
Japan
Facility Name
Nagano National Hospital
City
Ueda-shi
State/Province
Nagano
Country
Japan
Facility Name
The Nippon Dental University Niigata Hospital
City
Niigata-shi
State/Province
Niigata
Country
Japan
Facility Name
Osaka Dental University Hospital
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Osaka Prefectural General Medical Center
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Meikai University Hospital
City
Sakado-shi
State/Province
Saitama
Country
Japan
Facility Name
Shizuoka Medical Center
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Tochigi National Hospital
City
Utsunomiya-shi
State/Province
Tochigi
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachiouji-shi
State/Province
Tokyo
Country
Japan
Facility Name
Japan Red Cross Musashino Hospital
City
Musashino-shi
State/Province
Tokyo
Country
Japan
Facility Name
Showa University Dental Hospital
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kanto Medical Center NTT EC
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22284900
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191200&StudyName=Study%20To%20Evaluate%20Efficacy%20And%20Safety%20Of%20An%20Additional%20Dose%20Of%20Celecoxib%20%28YM177%29%20In%20Patients%20With%20Post-Tooth%20Extraction%20Pain
Description
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Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain

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