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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Pain

Treatments: Drug: Tramadol plus Acetaminophen; Drug: Tramadol Hydrochloride; Drug: Acetaminophen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737048

CR015109

JNS013-JPN-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 3 patient groups

Tramadol plus Acetaminophen and Placebo

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: Tramadol plus Acetaminophen

Tramadol and Placebo

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: Tramadol Hydrochloride

Acetaminophen and Placebo

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: Acetaminophen