A Confirmatory Study of JNS013 in Patients With Post-tooth-extraction Pain

• Effectiveness of JNS013 to TRAM and APAP ; Total pain relief over 8 hours (TOTPAR 0-8 hr); as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration. ] [ Designated as safety issue: No ]
  

• Total pain relief (TOTPAR ) at each assesement period as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 4 hours after the study drug administration (0-4 hours), and 4-8 hours ] [ Designated as safety issue: No ]
  
• Sum of pain intensity difference (SPID) (0-8 hr, 0-4 hr, 4-8 hr), pain relief combined with pain intensity difference (SPRID) (0-8 hr, 0-4 hr, 4-8 hr) as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
  
• The mean and mean changes over time for VAS24 score as measured by VAS. [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
  
• The mean and mean changes over time for Pain intensity difference (PID), Pain relief rating (PAR), Pain Relief combined with pain Intensity Difference (PRID) as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
  
• Time from investigational treatment to drug response (time to response);Time from drug response to recurrence of pain (duration of response) [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
  

JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with acetaminophen (APAP). It is expected to have an intermediate effect between narcotic analgesics and NSAIDs (non-steroid anti-inflammatory drugs). Both TRAM and APAP, the active ingredients of JNS013, were approved in Japan and have been in use for years. APAP is a medication with the indication for "post-dental-treatment pain". This study is an active drug-controlled, double-blind (neither patient nor physician knows the assigned study drug medication name ), parallel-group, comparative study to exclude biases in effectiveness and safety assessments, and verify the significance of combination of JNS013 versus TRAM and APAP with the indication for "post-dental-treatment pain". Patients with post-tooth-extraction of mandibular impacted wisdom tooth will be enrolled. The 8 hour period after the study drug administration will be considered the double-blind period. Patients who meet the criteria for the double-blind period will receive the study drug as a single oral dose within 30 minitues after scoring at least 50.0 mm in VAS (Visual Analog Scale) after tooth-extraction. The JNS013 group receives 2 tabs of JNS013 and 2 capsules of placebo. TRAM group receives 2 tabs of TRAM and 2 capsules of placebo. APAP group receives 2 tabs of APAP and 2 capsules of placebo.