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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tramadol plus Acetaminophen and Placebo

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).

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

Tramadol plus Acetaminophen

Intervention Type DRUG

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.

Tramadol and Placebo

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).

Group Type EXPERIMENTAL

Tramadol Hydrochloride

Intervention Type DRUG

Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).

Placebo

Intervention Type DRUG

Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

Acetaminophen and Placebo

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).

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen two oral capsules will be administered once as 650 mg.

Placebo

Intervention Type DRUG

Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

Interventions

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Tramadol Hydrochloride

Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).

Intervention Type DRUG

Acetaminophen

Acetaminophen two oral capsules will be administered once as 650 mg.

Intervention Type DRUG

Placebo

Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

Intervention Type DRUG

Tramadol plus Acetaminophen

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.

Intervention Type DRUG

Other Intervention Names

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JNS013

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No