Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
NCT01062113
ABOUT THIS STUDY
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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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 255 | |||
Original Estimated Enrollment ICMJE | 448 | |||
Actual Study Completion Date ICMJE | August 2010 | |||
Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Initial dose:
Additional dose:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01062113 | |||
Other Study ID Numbers ICMJE | A3191200 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |