Phase 3 N=328 Randomized Double-blind Treatment

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

Pain · Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT00737048 ↗

Enrolled (actual)

328

Serious AEs

0.3%

Results posted

Aug 2013

Primary outcome: Primary: Total Pain Relief Based on Numerical Rating Scale (NRS) Score — 17.7; 12.4; 13.3 Units on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tramadol Hydrochloride (Drug); Acetaminophen (Drug); Placebo (Drug); Tramadol plus Acetaminophen (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Janssen Pharmaceutical K.K.
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Pain Relief Based on Numerical Rating Scale (NRS) Score	17.7; 12.4; 13.3	<0.0001 sig
SECONDARY Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours	9.6; 6.3; 7.4; 8.0; 6.1; 5.9	—
SECONDARY Sum of Pain Intensity Difference (SPID)	6.4; 2.9; 4.1	—
SECONDARY Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)	24.0; 15.3; 17.4	—
SECONDARY 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	-22.11; -4.28; -15.50; -36.79; -12.82; -26.68	—
SECONDARY 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	0.6; 0.1; 0.5; 0.9; 0.4; 0.7	—
SECONDARY 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	1.5; 0.7; 1.3; 2.3; 1.4; 2.0	—
SECONDARY 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	2.1; 0.8; 1.8; 3.2; 1.8; 2.7	—
SECONDARY Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy	47.6; 82.8; 53.5; 252.5; 207.9; 198.2	—
SECONDARY Percentage of Participants With Categorical Score for Patient Impressions	28.7; 16.4; 15.7; 55.8; 44.3; 53.5	—
SECONDARY Number of Participants Treated With a Relief Analgesic	37; 25; 54	—
SECONDARY Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain	19.4; 8.2; 9.6; 2.8; 0; 0	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT00737048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.