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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib

Criteria

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