Overview

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