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Completed

NCT Number: NCT01062113

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jyuzen General Hospital, Niihama-shi, Ehime, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

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

Placebo

Drug

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 outcomes

  1. Efficacy Rate (Percentage) of Patient's Impression

    Time frame: 2 hours post-additional dose

    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 outcomes

  1. Number of Participants in Each Pain Intensity (PI) With 4 Categories

    Time frame: 2 hours after additional dose

    Pain intensity was entered in the patient diary on the following categories: "No pain", "Mild pain", "Moderate pain" and "Severe pain".

  2. Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: 2 hours post-additional dose

    The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.

  3. Differences in Pain Intensity (PI) Measured by VAS Among Participants

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

    The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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