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

Viatris

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01062113

A3191200

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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255 participants in 3 patient groups, including a placebo group

Celecoxib 400mg

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

Celecoxib 200mg

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo