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Completed

NCT Number: NCT00737048

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

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.

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Key information

Conditions

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

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Isehara, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol Hydrochloride

Drug

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

Acetaminophen

Drug

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

Placebo

Drug

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

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.

Other names: JNS013

Primary outcomes

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

    Time frame: 8 hours

    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 outcomes

  1. 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

    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.

  2. Sum of Pain Intensity Difference (SPID)

    Time frame: Baseline up to 8 hours post-administration of study treatment

    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).

  3. Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)

    Time frame: Baseline up to 8 hours post-administration of study treatment

    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).

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. Percentage of Participants With Categorical Score for Patient Impressions

    Time frame: Baseline up to 8 hours post-administration of study treatment

    Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.

  10. Number of Participants Treated With a Relief Analgesic

    Time frame: Baseline up to 8 hours post-administration of study treatment

    Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.

  11. 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

    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).

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study title

A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 18, 2008
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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