Clinical trial NCT00737048: A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
Official title: A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Postoperative Pain
Keywords: Pain
Tooth extraction
Oral surgery
Postoperative pain
JNS013
Tramadol hydrochloride
Acetaminophen
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 328
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Pain Relief Based on Numerical Rating Scale (NRS) Score
timeFrame: 8 hours
Secondary outcomes:
measure: Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours
timeFrame: Baseline up to 8 hours post-administration of study treatment
measure: Sum of Pain Intensity Difference (SPID)
timeFrame: Baseline up to 8 hours post-administration of study treatment
measure: Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)
timeFrame: Baseline up to 8 hours post-administration of study treatment
measure: 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
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
measure: 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
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
measure: 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
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
measure: 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
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
measure: Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy
timeFrame: Baseline up to 8 hours post-administration of study treatment
measure: Percentage of Participants With Categorical Score for Patient Impressions
timeFrame: Baseline up to 8 hours post-administration of study treatment
measure: Number of Participants Treated With a Relief Analgesic
timeFrame: Baseline up to 8 hours post-administration of study treatment
measure: Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain
timeFrame: Baseline up to 8 hours post-administration of study treatment
Other outcomes:
Locations:
city: Isehara
country: Japan
city: Kitakyushu
country: Japan
city: Kumamoto
country: Japan
city: Ohta-Ku
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Shimotsuga
country: Japan
city: Shimotsuke
country: Japan
city: Tokyo
country: Japan
city: Yokohama N/A
country: Japan
city: Yokohama
country: Japan
city: Yokosuka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: