A Confirmatory Study of JNS013 in Patients With Post-Tooth-Extraction Pain.
Information source: Janssen Pharmaceutical K.K.
Information obtained from ClinicalTrials.gov on October 31, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative; Pain
Intervention: Tramadol hydrochloride; acetaminophen; JNS013 (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Janssen Pharmaceutical K.K. Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.
Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
Summary
The purpose of this study is to evaluate the effectiveness and safety of JNS013 with single
oral dose administration in patients with post-tooth-extraction pain with extraction of
mandibular impacted wisdom tooth. In addition, the significance of JNS013 as a combination
drug and its usefulness in post-tooth-extraction pain will be verified, compared with single
oral dose administration of tramadol hydrochloride (TRAM) or acetaminophen (APAP).
Clinical Details
Official title: A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain.
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Total pain relief during the period for 8 hours after the start of study drug administration.
Secondary outcome: Total pain relief, sum of pain intensity difference, sum of pain relief combined with pain intensity difference, difference of VAS and the change, pain intensity difference and the change, pain relief rating and the change, etc.
Detailed description:
Since JNS013 is a combination of TRAM acting as a weak opioid with APAP inhibiting central
COX-3, it is expected to have an intermediate effect between narcotic analgesics and NSAIDs
(non-steroid anti-inflammatory drugs) Both TRAM and APAP, the active ingredients of JNS013,
were approved in Japan and are clinically being used in long years. APAP, one of the active
ingredients of JNS013, is a medication with the indication for "post-dental-treatment pain".
This study is an active drug-controlled, double-blind (neither patient nor physician knows
the assigned study drug medication name), parallel-group comparative study to exclude biases
in effectiveness and safety assessments, and verify the significance of combination of JNS013
vs. TRAM and APAP with the indication for "post-dental-treatment pain". Patients with
post-tooth-extraction of mandibular impacted wisdom tooth will be enrolled. During the period
for 8 hours after the study drug administration will be considered the double-blind period.
Patients who meet the criteria for the double-blind period will receive the investigational
products (2 tablets and 2 capsules) with single oral dose administration. In addition, the
study drug will be administered within 30 minutes after indicating at least 50. 0mm in VAS
(Visual Analog Scale) accompanied by tooth-extraction. JNS013 group: 2 tabs of JNS013 and 2
caps of placebo. TRAM group: 2 tabs of TRAM and 2 caps of placebo. APAP group: 2 tabs of APAP
and 2 caps of placebo.
Eligibility
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients planned to receive a tooth extraction of one mandibular impacted wisdom
tooth
- Patients who require bone removal and separation of the crown at tooth extraction
Exclusion Criteria:
- Patients with conditions for which TRAM are contraindicated
- Patients with conditions for which APAP are contraindicated
- Patients with history of convulsions or the possibility of convulsive seizures
- Pregnant patients or those who may be pregnant, lactating mothers, and those who wish
pregnancy during the study period
- Patients with concurrent, previous, or possible alcohol dependence, drug dependence or
narcotic addiction
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
236-0004 Yokohama N/A, Japan; Recruiting
329-0431 Tochigi, Japan; Recruiting
540-0008 Osaka, Japan; Recruiting
321-0027 Mibu N/A, Japan; Recruiting
230-0063 Yokohama N/A, Japan; Recruiting
860-0811 Kumamoto N/A, Japan; Recruiting
003-0027 Sapporo, Japan; Recruiting
145-0062 Tokyo, Japan; Recruiting
113-0034 Tokyo N/A, Japan; Recruiting
259-1193 Isehara, Japan; Recruiting
160-0023 Tokyo N/A, Japan; Recruiting
238-0003 Yokosuka, Japan; Recruiting
803-0844 Fukuoka, Japan; Recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: March 2008
Last updated: September 26, 2008
|
