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

Janssen Pharmaceutical K.K.328 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

328

Conditions

Pain Postoperative Pain

Interventions

Tramadol HydrochlorideDRUG

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

AcetaminophenDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Isehara, Japan

Unnamed facility

Kitakyushu, Japan

Unnamed facility

Kumamoto, Japan

Unnamed facility

Ohta-Ku, Japan

Outcomes

Primary Outcomes

Total Pain Relief Based on Numerical Rating Scale (NRS) Score

Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.

Time frame: 8 hours

Secondary Outcomes

Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours

Time frame: Baseline up to 8 hours post-administration of study treatment

Sum of Pain Intensity Difference (SPID)

Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point \[8 hour\] score minus baseline \[0 hour\] score).

Time frame: Baseline up to 8 hours post-administration of study treatment

Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)

The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point \[8 hour\] score minus baseline \[0 hour\] score).

Data from ClinicalTrials.gov

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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.

Unnamed facility

Osaka, Japan

Unnamed facility

Sapporo, Japan

Unnamed facility

Shimotsuga, Japan

Unnamed facility

Shimotsuke, Japan

Unnamed facility

Tokyo, Japan

Unnamed facility

Yokohama, Japan

...and 1 more locations

Time frame: Baseline up to 8 hours post-administration of study treatment

Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment

Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment

The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment

Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment

Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.

Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy

Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.

Time frame: Baseline up to 8 hours post-administration of study treatment

Percentage of Participants With Categorical Score for Patient Impressions

Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.

Time frame: Baseline up to 8 hours post-administration of study treatment

Number of Participants Treated With a Relief Analgesic

Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.

Time frame: Baseline up to 8 hours post-administration of study treatment

Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain

Percentage of participants were assessed with treatment response based on "evaluation criteria for efficacy of analgesics in post-tooth-extraction pain" for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as "very effective, effective, somewhat effective and ineffective" for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as "extremely useful, useful, not useful \& could not be assessed" for overall evaluation (OE).

Time frame: Baseline up to 8 hours post-administration of study treatment