PainPhase 3NCT00736853
An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
A Phase 3 study testing Tramadol Hydrochloride Plus Acetaminophen (Open-Label) and Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) in people with Pain, run by Janssen Pharmaceutical K.K. at 20 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol Hydrochloride Plus Acetaminophen (Open-Label) and Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 20 sitesJapan
- Study dates
- Jun 2008to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
- Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
- Outpatients
- Ambulatory participants without need for any supportive device or assistance during daily life
Who cannot join
- Participants with conditions for which opioids are contraindicated
- Participants with conditions for which acetaminophen is contraindicated
- Participants with history of convulsion or the possibility of convulsive seizure
- Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
- Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Aichi
Study site
Amagasaki
Study site
Chiba
Study site
Edogawa City
Study site
Fukuoka
Study site
Fukushima
Study site
Iruma
Study site
Kagoshima
Study site
Kawasaki
Study site
Kumagaya
Study site
Kurume
Study site
Meguro City
Study site
Minato
Study site
Niigata
Study site
Ohta-Ku
Study site
Okazaki
Study site
Sagamihara
Study site
Setagaya City
Study site
Shibuya City
Study site
Shinjuku-Ku
About this study
Official title: A Phase 3 Study of JNS013 in Patients With Chronic Pain
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
Read the detailed description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.
- Conditions
- Pain
- Being tested
- Tramadol Hydrochloride Plus Acetaminophen (Open-Label), Tramadol Hydrochloride Plus Acetaminophen (Double-Blind), Placebo (Double-Blind)
- Keywords
- Chronic pain, Acetoaminophen, Tramadol, Osteoarthritis of the knee, Low back pain
- Medical subject headings
- Pain, Chronic Pain, Osteoarthritis, Knee, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Hydrochloride Plus Acetaminophen (Open-Label)Drug
Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).
Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)Drug
Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.
Placebo (Double-Blind)Drug
Matching placebo will be given up to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen (Open-Label) | Experimental | Not described Receives: Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label) |
| Tramadol Hydrochloride Plus Acetaminophen (Double Blind) | Experimental | Not described Receives: Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) |
| Placebo (Double-Blind) | Placebo comparator | Not described Receives: Drug: Placebo (Double-Blind) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.
Measured: Day 28 of double-blind period
Secondary outcomes (22)
Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.
Measured: Day 1 of open-label period and Day 1 of double-blind period
Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.
Measured: Day 1 and Day 28 of double-blind period
Mean Pain Intensity (PI) Score During Open-Label Period
PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.
Measured: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period
Mean PI Score During Double-Blind Period
The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.
Measured: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period
Mean Pain Intensity Difference (PID) During the Open-Label Period
The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
Measured: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period
Mean PID During the Double-Blind Period
The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
Measured: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period
Mean Pain Relief (PAR) Score During the Open-Label Period
PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
Measured: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period
Mean PAR Score During the Double-Blind Period
PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
Measured: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period
Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period
The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.
Measured: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period
Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period
The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.
Measured: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period
Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period
The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
Measured: Day 1, and Day 8 of open-label period
Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period
The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
Measured: Day 1, 8, 15, 22 and 28 of double-blind period
Total Pain Relief (TOTPAR) Score During the Open-Label Period
The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.
Measured: Day 1 and Day 8 of open-label period
Total Pain Relief (TOTPAR) Score During the Double-Blind Period
The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.
Measured: Day 1, 8, 15, 22 and 28 of double-blind period
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period
The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.
Measured: Day 1, and Day 8 of open-label period
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period
The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
Measured: Day 1, 8, 15, 22 and 28 of double-blind period
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period
The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.
Measured: Day 1 and Day 14 of open-label period
Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period
The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.
Measured: Day 1 and Day 28 of double-blind period
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period
The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.
Measured: Day 1 and Day 14 of open-label period
Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period
The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.
Measured: Day 1 and Day 28 of double-blind period
Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period
The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.
Measured: Day 1 and Day 14 of open-label period
Change From Baseline in SF-36 at Day 28 of Double-Blind Period
The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.
Measured: Day 1 and Day 28 of double-blind period
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 startJun 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 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. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736853
- Sponsor's protocol ID
- CR015112
- Other IDs
- JNS013-JPN-04, NCT00736853
- Status last verified
- Jul 2013
- First submitted
- 14 Aug 2008
- Last updated
- 26 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of JNS013 in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT00736853
- Acronym / sponsor ID
- CR015112
- Conditions
- Pain
- Keywords
- Chronic pain, Acetoaminophen, Tramadol, Osteoarthritis of the knee, Low back pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Posted 26 Sep 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 tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
Detailed description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen (Open-Label) | Experimental | Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label) |
| Tramadol Hydrochloride Plus Acetaminophen (Double Blind) | Experimental | Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) |
| Placebo (Double-Blind) | Placebo comparator | Drug: Placebo (Double-Blind) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
- Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
- Outpatients
- Ambulatory participants without need for any supportive device or assistance during daily life
Key exclusion criteria (5 listed)
- Participants with conditions for which opioids are contraindicated
- Participants with conditions for which acetaminophen is contraindicated
- Participants with history of convulsion or the possibility of convulsive seizure
- Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
- Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period
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 Hydrochloride Plus Acetaminophen (Open-Label)Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets). | Drug | Tramadol Hydrochloride Plus Acetaminophen (Open-Label) |
| Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks. | Drug | Tramadol Hydrochloride Plus Acetaminophen (Double Blind) |
| Placebo (Double-Blind)Matching placebo will be given up to 4 weeks. | Drug | Placebo (Double-Blind) |
Primary outcome
Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
Time frame: Day 28 of double-blind period
The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.
22 secondary outcomes
Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period
Time frame: Day 1 of open-label period and Day 1 of double-blind period
Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period
Time frame: Day 1 and Day 28 of double-blind period
Mean Pain Intensity (PI) Score During Open-Label Period
Time frame: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period
Mean PI Score During Double-Blind Period
Time frame: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period
Mean Pain Intensity Difference (PID) During the Open-Label Period
Time frame: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period
Mean PID During the Double-Blind Period
Time frame: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period
Mean Pain Relief (PAR) Score During the Open-Label Period
Time frame: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period
Mean PAR Score During the Double-Blind Period
Time frame: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period
Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period
Time frame: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period
Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period
Time frame: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period
Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period
Time frame: Day 1, and Day 8 of open-label period
Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period
Time frame: Day 1, 8, 15, 22 and 28 of double-blind period
Total Pain Relief (TOTPAR) Score During the Open-Label Period
Time frame: Day 1 and Day 8 of open-label period
Total Pain Relief (TOTPAR) Score During the Double-Blind Period
Time frame: Day 1, 8, 15, 22 and 28 of double-blind period
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period
Time frame: Day 1, and Day 8 of open-label period
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period
Time frame: Day 1, 8, 15, 22 and 28 of double-blind period
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period
Time frame: Day 1 and Day 14 of open-label period
Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period
Time frame: Day 1 and Day 28 of double-blind period
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period
Time frame: Day 1 and Day 14 of open-label period
Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period
Time frame: Day 1 and Day 28 of double-blind period
Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period
Time frame: Day 1 and Day 14 of open-label period
Change From Baseline in SF-36 at Day 28 of Double-Blind Period
Time frame: Day 1 and Day 28 of double-blind period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Phase III Study of JNS013 in Patients with Chronic 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. Clinical Trial study director
Janssen Pharmaceutical K.K.
20 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 Plus Acetaminophen (Open-Label) and Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) in people with Pain, run by Janssen Pharmaceutical K.K. at 20 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 4 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 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. Some participants in this study may receive a placebo. 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 26 Sep 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?
Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period (time frame: Day 28 of double-blind period). 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 26 Sep 2013.