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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Acetaminophen; Tramadol

Criteria

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