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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.255 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

255

Conditions

Pain

Interventions

CelecoxibDRUG

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

CelecoxibDRUG

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

PlaceboDRUG

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

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (22)

Jyuzen General Hospital

Niihama-shi, Ehime, Japan

Kyushu Dental College Hospital

Kitakyusyu-shi, Fukuoka, Japan

Outcomes

Primary Outcomes

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.

Time frame: 2 hours post-additional dose

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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.

Time frame: Pre-additional dose (baseline) and 2 hours post-additional dose

Data from ClinicalTrials.gov

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