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| Sponsor: | Janssen Pharmaceutical K.K. |
|---|---|
| Information provided by: | Janssen Pharmaceutical K.K. |
| ClinicalTrials.gov Identifier: | NCT00737048 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Postoperative |
Drug: Tramadol Hydrochloride /Acetaminophen and Placebo Drug: Tramadol Hydrochloride and Placebo Drug: Acetaminophen and Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-blind Comparative Study of JNS013 in Patients With Post-tooth-extraction Pain |
| Enrollment: | 396 |
| Study Start Date: | March 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
001: Experimental
Tramadol Hydrochloride /Acetaminophen and Placebo 2 tablets containing active drug and 2 tablets of placebo
|
Drug: Tramadol Hydrochloride /Acetaminophen and Placebo
2 tablets containing active drug and 2 tablets of placebo
|
|
002: Experimental
Tramadol Hydrochloride and Placebo 2 tablets containing active drug and 2 tablets of placebo
|
Drug: Tramadol Hydrochloride and Placebo
2 tablets containing active drug and 2 tablets of placebo
|
|
003: Experimental
Acetaminophen and Placebo 2 tablets containing active drug and 2 tablets of placebo
|
Drug: Acetaminophen and Placebo
2 tablets containing active drug and 2 tablets of placebo
|
JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with acetaminophen (APAP). 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 have been in use for years. APAP 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 versus TRAM and APAP with the indication for "post-dental-treatment pain". Patients with post-tooth-extraction of mandibular impacted wisdom tooth will be enrolled. The 8 hour period 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 study drug as a single oral dose within 30 minitues after scoring at least 50.0 mm in VAS (Visual Analog Scale) after tooth-extraction. The JNS013 group receives 2 tabs of JNS013 and 2 capsules of placebo. TRAM group receives 2 tabs of TRAM and 2 capsules of placebo. APAP group receives 2 tabs of APAP and 2 capsules of placebo.
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Janssen Pharmaceutical K.K., Japan ( Director of Clinical R&D Dept. 3 ) |
| Study ID Numbers: | CR015109, JNS013-JPN-03 |
| Study First Received: | August 14, 2008 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00737048 History of Changes |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
|
Pain Tooth extraction Oral surgery |
Postoperative pain Tramadol hydrochloride Acetaminophen |
|
Tramadol Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Acetaminophen Analgesics, Opioid |