A Confirmatory Study of JNS013 in Patients With Post-tooth-extraction Pain
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-blind Comparative Study of JNS013 in Patients With Post-tooth-extraction Pain |
- Effectiveness of JNS013 to TRAM and APAP ; Total pain relief over 8 hours (TOTPAR 0-8 hr); as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration. ] [ Designated as safety issue: No ]
- Total pain relief (TOTPAR ) at each assesement period as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 4 hours after the study drug administration (0-4 hours), and 4-8 hours ] [ Designated as safety issue: No ]
- Sum of pain intensity difference (SPID) (0-8 hr, 0-4 hr, 4-8 hr), pain relief combined with pain intensity difference (SPRID) (0-8 hr, 0-4 hr, 4-8 hr) as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
- The mean and mean changes over time for VAS24 score as measured by VAS. [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
- The mean and mean changes over time for Pain intensity difference (PID), Pain relief rating (PAR), Pain Relief combined with pain Intensity Difference (PRID) as measured by the numerical rating scale of 0 (complete relief) to 4 (no relief). [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
- Time from investigational treatment to drug response (time to response);Time from drug response to recurrence of pain (duration of response) [ Time Frame: From the baseline (after tooth extraction but before the study drug administration) to 8 hours after the study drug administration ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 001
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
|
|
Experimental: 002
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
|
|
Experimental: 003
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
|
Detailed Description:
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:
- 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
Contacts and Locations| Japan | |
| Bunkyo, Japan | |
| Isehara, Japan | |
| Kitakyushu, Japan | |
| Kumamoto N/A, Japan | |
| Ohta-Ku, Japan | |
| Osaka, Japan | |
| Sapporo, Japan | |
| Shimotsuga, Japan | |
| Shimotsuke, Japan | |
| Shinjuku, Japan | |
| Yokohama N/A, Japan | |
| Yokosuka, Japan | |
| Study Director: | Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director of Clinical R&D Dept. 3, Janssen Pharmaceutical K.K., Japan |
| ClinicalTrials.gov Identifier: | NCT00737048 History of Changes |
| Other Study ID Numbers: | CR015109, JNS013-JPN-03 |
| Study First Received: | August 14, 2008 |
| Last Updated: | February 9, 2012 |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Keywords provided by Janssen Pharmaceutical K.K.:
|
Pain Tooth extraction Oral surgery |
Postoperative pain Tramadol hydrochloride Acetaminophen |
Additional relevant MeSH terms:
|
Acetaminophen Tramadol Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on June 17, 2013