Back to resultsA Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Primary Purpose
Pain, Diabetic Neuropathies, Neuralgia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tapentadol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Chronic pain, Diabetic Neuropathic Pain, Neuralgia, Postherpetic, Tapentadol hydrochloride extended-release, JNS024ER, Placebo
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tapentadol
Placebo
Arm Description
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.
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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".
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01124617
First Posted
April 22, 2010
Last Updated
December 11, 2013
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01124617
Brief Title
A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Official Title
Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Diabetic Neuropathies, Neuralgia, Postherpetic Neuralgia
Keywords
Chronic pain, Diabetic Neuropathic Pain, Neuralgia, Postherpetic, Tapentadol hydrochloride extended-release, JNS024ER, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tapentadol
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Tapentadol
Other Intervention Name(s)
JNS024ER
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11
Description
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.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Title
Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)
Description
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.
Time Frame
Week 12
Title
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Description
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.
Time Frame
Week 8 and Week 12
Title
Number of Participants With Categorical Scores on Physician's Global Assessment Scale
Description
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".
Time Frame
Week 8 and Week 12
Title
Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Number of Participants With Awakenings Based on Sleep Questionnaire
Description
Number of awakenings was related to "How many times did the participant wake up during the night". Lesser number signifies better sleep.
Time Frame
Baseline and Week 12
Title
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Description
Participants rated the overall quality of sleep last night as excellent, good, fair and poor.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Description
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.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Chigasaki
Country
Japan
City
Chuo-Ku
Country
Japan
City
Fukuoka
Country
Japan
City
Inashiki
Country
Japan
City
Isesaki
Country
Japan
City
Izumisano
Country
Japan
City
Kanuma
Country
Japan
City
Katsushika-Ku
Country
Japan
City
Kawaguchi
Country
Japan
City
Kooriyama
Country
Japan
City
Kurume
Country
Japan
City
Kyoto
Country
Japan
City
Matsue
Country
Japan
City
Matsumoto
Country
Japan
City
Minato-Ku
Country
Japan
City
Mitaka
Country
Japan
City
Nagano
Country
Japan
City
Nagoya-City
Country
Japan
City
Nagoya
Country
Japan
City
Obihiro
Country
Japan
City
Ohta-Ku
Country
Japan
City
Ohtsu
Country
Japan
City
Okayama
Country
Japan
City
Omuta
Country
Japan
City
Osaka
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Setagaya
Country
Japan
City
Shimotsuga
Country
Japan
City
Tokyo
Country
Japan
City
Ube
Country
Japan
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
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