PainPhase 2NCT01124617
A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
A Phase 2 study testing Tapentadol in people with Pain and Diabetic Neuropathies, run by Janssen Pharmaceutical K.K. at 31 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Diabetic Neuropathies, Neuralgia
- What is being tested?
- Tapentadol
- 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
- 31 sitesJapan
- Study dates
- Jun 2010to Apr 2011
- 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 painful diabetic neuropathy or postherpetic neuralgia continuing for at least 12 weeks before consent
- Participants with adjuvant analgesics (antidepressants, antiepileptics and diabetic peripheral neuropathy drugs) or non-opioid treatment and dissatisfied with current treatment (in sense of efficacy and/or safety) for at least consecutive 14 days during the 12 weeks before consent
- Participants have not experienced treatment with conventional opioids, except for the following cases: Short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent; and temporal use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (for example, for antitussive) more than 2 days before consent
- Mean pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale during 48 hours before consent and the Investigator or Sub-investigator considers that the participant should be treated with an opioid analgesic
- HbA1c within 4 weeks before consent less than or equal to 11percent (in participants with diabetic neuropathic pain)
Who cannot join
- Participants have been treated or treated with a monoamine oxidase inhibitor within 14 days before consent
- Current or a history of epilepsy or convulsive disorders or hypersensitivity to opioid analgesics
- Suggested of intracranial hypertension (for example, traumatic encephalopathy)
- Participants who have complicated condition with uncontrolled or clinically significant arrhythmia, or neuropsychiatric disorders
- Participants with moderately to severely impaired hepatic function, or severely impaired renal function
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
Study site
Chigasaki
Study site
Chūōku
Study site
Fukuoka
Study site
Inashiki
Study site
Isesaki
Study site
Izumisano
Study site
Kanuma
Study site
Katsushika-ku
Study site
Kawaguchi
Study site
kooriyama
Study site
Kurume
Study site
Kyoto
Study site
Matsue
Study site
Matsumoto
Study site
Minatoku
Study site
Mitaka
Study site
Nagano
Study site
Nagoya
Study site
Obihiro
Study site
Ohta-Ku
Study site
Ohtsu
Study site
Okayama
Study site
Omuta
Study site
Osaka
Study site
Sapporo
Study site
Sendai
Study site
Setagaya City
Study site
Shimotsuga
Study site
Tokyo
Study site
Ube
Study site
Yokohama
About this study
Official title: Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).
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), and parallel-group (each group of participant will be treated at the same time) comparison study in Japanese participants with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The duration of study will be 14 weeks. The study consists of 3 parts: Screening (1 Week before study commences on Day 1); Treatment (12 weeks and will include 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 up to12 week]); and Follow-up (1 Week). Tapentadol hydrochloride ER oral tablet or matching placebo will be administered twice daily for 12 weeks. Efficacy of the participants will primarily be evaluated through Numerical Rating Scale (NRS). Participants' safety will be monitored throughout the study.
- Conditions
- Pain, Diabetic Neuropathies, Neuralgia, Postherpetic Neuralgia
- Being tested
- Tapentadol, Placebo
- Keywords
- Chronic pain, Diabetic Neuropathic Pain, Neuralgia, Postherpetic, Tapentadol hydrochloride extended-release, JNS024ER, Placebo
- Medical subject headings
- Pain, Diabetic Neuropathies, Neuralgia, Neuralgia, Postherpetic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Also called JNS024ER
Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
PlaceboDrug
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol | Experimental | Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. Receives: Drug: Tapentadol |
| Placebo | Placebo comparator | Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12
Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.
Measured: Baseline and Week 12
Secondary outcomes (12)
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11
Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)
Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 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 and Week 12
Number of Participants With Categorical Scores 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 "ineffective".
Measured: Week 8 and Week 12
Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
The 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). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. 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. Lower score indicates an improvement in pain.
Measured: Baseline and Week 12
Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
The 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). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. 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. Lower score indicates an improvement in pain.
Measured: Baseline and Week 12
Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12
The 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. Lower score indicates an improvement in pain.
Measured: Baseline and Week 12
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Sleep Latency was related to "How long after bedtime or lights out did the participant fall asleep last night ". Decrease in time indicates an improvement.
Measured: Baseline and Week 12
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Time slept was related to "How long did the participant sleep last night". The mean change for the time in hours slept during the last night was reported.
Measured: Baseline and Week 12
Number of Participants With Awakenings Based on Sleep Questionnaire
Number of awakenings was related to "How many times did the participant wake up during the night". Lesser number signifies better sleep.
Measured: Baseline and Week 12
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Participants rated the overall quality of sleep last night as excellent, good, fair and poor.
Measured: Baseline and Week 12
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
The 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 and 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 startJun 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124617
- Sponsor's protocol ID
- CR017002
- Other IDs
- JNS024ER-JPN-N22
- Status last verified
- Dec 2013
- First submitted
- 22 Apr 2010
- Last updated
- 13 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. 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 Diabetic Neuropathic Pain or Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT01124617
- Acronym / sponsor ID
- CR017002
- Conditions
- Pain, Diabetic Neuropathies, Neuralgia, Postherpetic Neuralgia
- Keywords
- Chronic pain, Diabetic Neuropathic Pain, Neuralgia, Postherpetic, Tapentadol hydrochloride extended-release, JNS024ER, Placebo
- 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
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 26 Jun 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 investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).
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), and parallel-group (each group of participant will be treated at the same time) comparison study in Japanese participants with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The duration of study will be 14 weeks. The study consists of 3 parts: Screening (1 Week before study commences on Day 1); Treatment (12 weeks and will include 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 up to12 week]); and Follow-up (1 Week). Tapentadol hydrochloride ER oral tablet or matching placebo will be administered twice daily for 12 weeks. Efficacy of the participants will primarily be evaluated through Numerical Rating Scale (NRS). Participants' 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Experimental | Drug: TapentadolTapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. |
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 painful diabetic neuropathy or postherpetic neuralgia continuing for at least 12 weeks before consent
- Participants with adjuvant analgesics (antidepressants, antiepileptics and diabetic peripheral neuropathy drugs) or non-opioid treatment and dissatisfied with current treatment (in sense of efficacy and/or safety) for at least consecutive 14 days during the 12 weeks before consent
- Participants have not experienced treatment with conventional opioids, except for the following cases: Short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent; and temporal use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (for example, for antitussive) more than 2 days before consent
- Mean pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale during 48 hours before consent and the Investigator or Sub-investigator considers that the participant should be treated with an opioid analgesic
- HbA1c within 4 weeks before consent less than or equal to 11percent (in participants with diabetic neuropathic pain)
Key exclusion criteria (5 listed)
- Participants have been treated or treated with a monoamine oxidase inhibitor within 14 days before consent
- Current or a history of epilepsy or convulsive disorders or hypersensitivity to opioid analgesics
- Suggested of intracranial hypertension (for example, traumatic encephalopathy)
- Participants who have complicated condition with uncontrolled or clinically significant arrhythmia, or neuropsychiatric disorders
- Participants with moderately to severely impaired hepatic function, or severely impaired renal function
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 |
|---|---|---|
| TapentadolAlso: JNS024ERTapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. | Drug | Tapentadol |
| PlaceboMatching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12
Time frame: Baseline and Week 12
Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.
12 secondary outcomes
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Percentage of Participants With Treatment Response Based on 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 and Week 12
Number of Participants With Categorical Scores on Physician's Global Assessment Scale
Time frame: Week 8 and Week 12
Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
Time frame: Baseline and Week 12
Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
Time frame: Baseline and Week 12
Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Time frame: Baseline and Week 12
Number of Participants With Awakenings Based on Sleep Questionnaire
Time frame: Baseline and Week 12
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Time frame: Baseline and Week 12
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- 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., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
31 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 in people with Pain and Diabetic Neuropathies, run by Janssen Pharmaceutical K.K. at 31 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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 26 Jun 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 Average Numerical Rating Scale (NRS) Score at Week 12 (time frame: Baseline and 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 13 Jan 2014.