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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Jyuzen General Hospital
Niihama-shi, Ehime, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01062113
Pfizer
Completed
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain

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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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
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.


*   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
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01062113
A3191200
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

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