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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00737048
First received: August 14, 2008
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Pain
Postoperative Pain
Drug: Tramadol Hydrochloride
Drug: Acetaminophen
Drug: Placebo
Drug: Tramadol plus Acetaminophen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Total Pain Relief Based on Numerical Rating Scale (NRS) Score [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    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.

  • Sum of Pain Intensity Difference (SPID) [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).

  • Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).

  • 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 [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.

  • 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 [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed 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. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.

  • 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 [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Pain Relief (PAR) was assessed 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. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.

  • 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 [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.

  • Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.

  • Percentage of Participants With Categorical Score for Patient Impressions [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.

  • Number of Participants Treated With a Relief Analgesic [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.

  • Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain [ Time Frame: Baseline up to 8 hours post-administration of study treatment ] [ Designated as safety issue: No ]
    Percentage of participants were assessed with treatment response based on "evaluation criteria for efficacy of analgesics in post-tooth-extraction pain" for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as "very effective, effective, somewhat effective and ineffective" for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as "extremely useful, useful, not useful & could not be assessed" for overall evaluation (OE).


Enrollment: 328
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: Tramadol plus Acetaminophen and Placebo
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
Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.
Drug: Tramadol plus Acetaminophen
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.
Other Name: JNS013
Experimental: Tramadol and Placebo
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
Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).
Drug: Placebo
Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.
Experimental: Acetaminophen and Placebo
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
Acetaminophen two oral capsules will be administered once as 650 mg.
Drug: Placebo
Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.

Detailed Description:

This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm [no pain] to 100 mm [worst possible pain]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737048

Locations
Japan
Isehara, Japan
Kitakyushu, Japan
Kumamoto, Japan
Ohta-Ku, Japan
Osaka, Japan
Sapporo, Japan
Shimotsuga, Japan
Shimotsuke, Japan
Tokyo, Japan
Yokohama, Japan
Yokohama N/A, Japan
Yokosuka, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00737048     History of Changes
Other Study ID Numbers: CR015109, JNS013-JPN-03
Study First Received: August 14, 2008
Results First Received: March 25, 2013
Last Updated: June 26, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Pain
Tooth extraction
Oral surgery
Postoperative pain
JNS013
Tramadol hydrochloride
Acetaminophen

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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 July 28, 2014