Status:
COMPLETED
A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Pain
Postoperative Pain
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief 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.
Detailed Description
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-g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00737048
Start Date
March 1 2008
End Date
September 1 2008
Last Update
March 31 2016
Active Locations (11)
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1
Isehara, Japan
2
Kitakyushu, Japan
3
Kumamoto, Japan
4
Ohta-Ku, Japan