A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain

A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain

The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.

This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm [no pain] to 100 mm [worst possible pain]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.

Inclusion Criteria:

• Participants planned to receive a tooth extraction of one mandibular impacted wisdom tooth
• Participants who require bone removal and separation of the crown at tooth extraction
• Participants whose intensity of pain associated with tooth extraction within 2 hours after tooth extraction is greater than or equal to 50.0 millimeter on the visual analog scale (VAS)
• Participants who did not undergo general anesthesia or sedation at tooth extraction
• Participants without an abnormality (including laboratory test values) corresponding to Grade 3 in the "Criteria for severity classification of adverse drug reactions" during the pretreatment observation period

Exclusion Criteria:

• Participants with conditions for which tramadol is contraindicated
• Participants with conditions for which acetaminophen is contraindicated
• Participants with history of convulsions or the possibility of convulsive seizures
• Pregnant participants or those who may be pregnant, lactating mothers, and those who wish pregnancy during the study period
• Participants with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction