Clinical trial NCT00737048
Conditions: Pain Postoperative Pain
Keywords: Pain Tooth extraction Oral surgery Postoperative pain JNS013 Tramadol hydrochloride Acetaminophen
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-03-01; Completion date: 2008-09-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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-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.

Arms: arm 1: Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (\>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). arm 2: Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). arm 3: Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
Interventions: intervention 1: Tramadol Hydrochloride intervention 2: Acetaminophen intervention 3: Placebo intervention 4: Tramadol plus Acetaminophen
Intervention descriptions: intervention 1: Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg). intervention 2: Acetaminophen two oral capsules will be administered once as 650 mg. intervention 3: Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen. intervention 4: Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.

Protocol documents: