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

NCT00737048 | Completed Phase 3 Results

• 2 other identifiers: CR015109JNS013-JPN-03
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 11

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.

Conditions

Pain; Postoperative Pain

Keywords

Pain; Tooth extraction; Oral surgery; Postoperative pain; JNS013; Tramadol hydrochloride; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• Total Pain Relief Based on Numerical Rating Scale (NRS) Score

  Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.

  8 hours

Secondary Outcomes (11)

• Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours

  Baseline up to 8 hours post-administration of study treatment

• Sum of Pain Intensity Difference (SPID)

  Baseline up to 8 hours post-administration of study treatment

• Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)

  Baseline up to 8 hours post-administration of study treatment

• 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

  0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

• 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

  0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

Study Arms (3)

Tramadol plus Acetaminophen and Placebo

EXPERIMENTAL

Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (\>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).

Drug: Placebo; Drug: Tramadol plus Acetaminophen

Tramadol and Placebo

EXPERIMENTAL

Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).

Drug: Tramadol Hydrochloride; Drug: Placebo

Acetaminophen and Placebo

EXPERIMENTAL

Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).

Drug: Acetaminophen; Drug: Placebo

Interventions

Tramadol Hydrochloride DRUG

Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).

Tramadol and Placebo

Acetaminophen DRUG

Acetaminophen two oral capsules will be administered once as 650 mg.

Acetaminophen and Placebo

Placebo DRUG

Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

Acetaminophen and Placebo; Tramadol and Placebo; Tramadol plus Acetaminophen and Placebo

Tramadol plus Acetaminophen DRUG

Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.

Also known as: JNS013

Tramadol plus Acetaminophen and Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (11)

Unknown Facility

Isehara, Japan

Location

Unknown Facility

Kitakyushu, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Ohta-Ku, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Shimotsuga, Japan

Location

Unknown Facility

Shimotsuke, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Unknown Facility

Yokosuka, Japan

Location

Related Links

• A confirmatory study of JNS013 in patients with post-tooth-extraction pain

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Results Point of Contact

• Title: Medical Director
• Organization: JANSSEN PHARMACEUTICAL. K.K. , Neuroscience Department, Clinical Science Division

+81-3-4411-5509

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 31, 2016
• Results First Posted: August 1, 2013

Record last verified: 2016-03

Locations

JP (11)