PainPhase 3NCT00737048
A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
A Phase 3 study testing Tramadol Hydrochloride, Acetaminophen and Tramadol plus Acetaminophen in people with Pain and Postoperative Pain, run by Janssen Pharmaceutical K.K. at 11 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Pain, Postoperative Pain
- What is being tested?
- Tramadol Hydrochloride, Acetaminophen and Tramadol plus Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 11 sitesJapan
- Study dates
- Mar 2008to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Study site
Isehara
Study site
Kitakyushu
Study site
Kumamoto
Study site
Ohta-Ku
Study site
Osaka
Study site
Sapporo
Study site
Shimotsuga
Study site
Shimotsuke
Study site
Tokyo
Study site
Yokohama
Study site
Yokosuka
About this study
Official title: A Double-Blind Comparative Study of JNS013 in Patients 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.
Read the 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.
- Conditions
- Pain, Postoperative Pain
- Being tested
- Tramadol Hydrochloride, Acetaminophen, Placebo, Tramadol plus Acetaminophen
- Keywords
- Pain, Tooth extraction, Oral surgery, Postoperative pain, JNS013, Tramadol hydrochloride, Acetaminophen
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HydrochlorideDrug
Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).
AcetaminophenDrug
Acetaminophen two oral capsules will be administered once as 650 mg.
PlaceboDrug
Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.
Tramadol plus AcetaminophenDrug
Also called JNS013
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Acetaminophen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Secondary outcomes (11)
Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 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.
Measured: Baseline up to 8 hours post-administration of study treatment
Sum of Pain Intensity Difference (SPID)
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).
Measured: Baseline up to 8 hours post-administration of study treatment
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)
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).
Measured: 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
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.
Measured: 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
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.
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
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
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.
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
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
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.
Measured: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy
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.
Measured: Baseline up to 8 hours post-administration of study treatment
Percentage of Participants With Categorical Score for Patient Impressions
Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.
Measured: Baseline up to 8 hours post-administration of study treatment
Number of Participants Treated With a Relief Analgesic
Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.
Measured: Baseline up to 8 hours post-administration of study treatment
Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain
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).
Measured: Baseline up to 8 hours post-administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737048
- Sponsor's protocol ID
- CR015109
- Other IDs
- JNS013-JPN-03
- Status last verified
- Mar 2016
- First submitted
- 14 Aug 2008
- Last updated
- 31 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain
- ClinicalTrials.gov ID
- NCT00737048
- Acronym / sponsor ID
- CR015109
- Conditions
- Pain, Postoperative Pain
- Keywords
- Pain, Tooth extraction, Oral surgery, Postoperative pain, JNS013, Tramadol hydrochloride, Acetaminophen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Posted 1 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol plus Acetaminophen and Placebo | Experimental | Drug: Placebo, Drug: Tramadol plus AcetaminophenTramadol 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). |
| Tramadol and Placebo | Experimental | Drug: Tramadol Hydrochloride, Drug: PlaceboTramadol 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). |
| Acetaminophen and Placebo | Experimental | Drug: Acetaminophen, Drug: PlaceboAcetaminophen 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). |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol HydrochlorideTramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg). | Drug | Tramadol and Placebo |
| AcetaminophenAcetaminophen two oral capsules will be administered once as 650 mg. | Drug | Acetaminophen and Placebo |
| PlaceboTwo oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen. | Drug | Acetaminophen and Placebo, Tramadol and Placebo, Tramadol plus Acetaminophen and Placebo |
| Tramadol plus AcetaminophenAlso: JNS013Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively. | Drug | Tramadol plus Acetaminophen and Placebo |
Primary outcome
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.
11 secondary outcomes
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
Sum of Pain Intensity Difference (SPID)
Time frame: Baseline up to 8 hours post-administration of study treatment
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)
Time frame: 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
Time frame: 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
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
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
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
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
Percentage of Participants With Categorical Score for Patient Impressions
Time frame: Baseline up to 8 hours post-administration of study treatment
Number of Participants Treated With a Relief Analgesic
Time frame: Baseline up to 8 hours post-administration of study treatment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A confirmatory study of JNS013 in patients with post-tooth-extraction painLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol Hydrochloride, Acetaminophen and Tramadol plus Acetaminophen in people with Pain and Postoperative Pain, run by Janssen Pharmaceutical K.K. at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pain Relief Based on Numerical Rating Scale (NRS) Score (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.