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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
History of Changes

February 2, 2010
October 17, 2012
April 2010
August 2010   (final data collection date for primary outcome measure)
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.
Patient's impression (rate of the patient's assessment as "it worked well" and "it worked") [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01062113 on ClinicalTrials.gov Archive Site
  • 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.
  • Pain intensity (4 categorical) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Pain intensity (VAS) [ Time Frame: 2 days ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
  • 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
  • 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
    Intervention: Drug: Celecoxib
  • Experimental: Celecoxib 200mg
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01062113
A3191200
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP