PainPhase 2NCT01124604
An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
A Phase 2 study testing Tapentadol Hydrochloride in people with Pain and Low Back Pain, run by Janssen Pharmaceutical K.K. at 19 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Low Back Pain, Back Pain
- What is being tested?
- Tapentadol Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 19 sitesJapan
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 2
- 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 chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
- Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
- Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
- Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
- Participants who are able to visit the medical institutions throughout the study period
Who cannot join
- Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
- Participants with current or a history of epilepsy or seizure disorders
- Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
- Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
- Participants with moderate to severe liver dysfunction or severe renal dysfunction
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Study site
Aichi
Study site
Amagasaki
Study site
Chiba
Study site
Chikushi
Study site
Edogawa City
Study site
Fukuoka
Study site
Fukushima
Study site
Hiratsuka
Study site
Kawasaki
Study site
Kōtō City
Study site
Matsudo
Study site
Meguro City
Study site
Minatoku
Study site
Niigata
Study site
Osaka
Study site
Sagamihara
Study site
Shibuya City
Study site
Shinjuku-Ku
Study site
Toshima-Ku
About this study
Official title: Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain
The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.
Read the detailed description
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. Participants' safety will be monitored throughout the study.
- Conditions
- Pain, Low Back Pain, Back Pain, Osteoarthritis, Knee
- Being tested
- Tapentadol Hydrochloride, Placebo
- Keywords
- Pain, Low Back Pain, Back Pain, Osteoarthritis, Knee, Tapentadol, Tapentadol Hydrochloride Extended Release
- Medical subject headings
- Pain, Low Back Pain, Back Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol HydrochlorideDrug
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
PlaceboDrug
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol Hydrochloride | Experimental | Not described Receives: Drug: Tapentadol Hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Measured: Baseline, Week 12
Secondary outcomes (14)
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.
Measured: Week 12
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Measured: Week 8, Week 12
Number of Participants With Response Based on Physician's Global Assessment Scale
Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "not effective".
Measured: Week 8, Week 12
Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".
Measured: Baseline, Week 12
Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).
Measured: Baseline, Week 12
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.
Measured: Baseline, Week 12
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?" and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.
Measured: Baseline, Week 12
Number of Participants With Awakenings Based on Sleep Questionnaire
Number of awakenings was addressed by the question: "How many times did you wake up during the night?'' and lesser number signified better sleep.
Measured: Baseline, Week 12
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.
Measured: Baseline, Week 12
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Measured: Baseline, Week 12
Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.
Measured: Baseline, Week 12
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 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
- NCT01124604
- Sponsor's protocol ID
- CR016999
- Other IDs
- JNS024ER-JPN-N21
- Status last verified
- May 2013
- First submitted
- 22 Apr 2010
- Last updated
- 14 May 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 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain
- ClinicalTrials.gov ID
- NCT01124604
- Acronym / sponsor ID
- CR016999
- Conditions
- Pain, Low Back Pain, Back Pain, Osteoarthritis, Knee
- Keywords
- Pain, Low Back Pain, Back Pain, Osteoarthritis, Knee, Tapentadol, Tapentadol Hydrochloride Extended Release
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 17 Apr 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, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.
Detailed description
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapentadol Hydrochloride | Experimental | Drug: Tapentadol Hydrochloride |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
- Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
- Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
- Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
- Participants who are able to visit the medical institutions throughout the study period
Key exclusion criteria (5 listed)
- Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
- Participants with current or a history of epilepsy or seizure disorders
- Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
- Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
- Participants with moderate to severe liver dysfunction or severe renal dysfunction
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 |
|---|---|---|
| Tapentadol HydrochlorideTapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion. | Drug | Tapentadol Hydrochloride |
| PlaceboPlacebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion. | Drug | Placebo |
Primary outcome
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
Time frame: Baseline, Week 12
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
14 secondary outcomes
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
Time frame: Week 12
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Time frame: Week 8, Week 12
Number of Participants With Response Based on Physician's Global Assessment Scale
Time frame: Week 8, Week 12
Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Time frame: Baseline, Week 12
Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Time frame: Baseline, Week 12
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Time frame: Baseline, Week 12
Number of Participants With Awakenings Based on Sleep Questionnaire
Time frame: Baseline, Week 12
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Time frame: Baseline, Week 12
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tapentadol Hydrochloride in people with Pain and Low Back Pain, run by Janssen Pharmaceutical K.K. at 19 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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Apr 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?
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 (time frame: Baseline, Week 12). 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 14 May 2013.