A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia

Overview[ - collapse ][ - ]

Purpose 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).
ConditionPain
Diabetic Neuropathies
Neuralgia
Postherpetic Neuralgia
InterventionDrug: Tapentadol
Drug: Placebo
PhasePhase 2
SponsorJanssen Pharmaceutical K.K.
Responsible PartyJanssen Pharmaceutical K.K.
ClinicalTrials.gov IdentifierNCT01124617
First ReceivedApril 22, 2010
Last UpdatedDecember 11, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateApril 22, 2010
Last Updated DateDecember 11, 2013
Start DateJune 2010
Estimated Primary Completion DateApril 2011
Current Primary Outcome MeasuresChange From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • 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] [Designated as safety issue: No]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) [Time Frame: Week 12] [Designated as safety issue: No]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 [Time Frame: Week 8 and Week 12] [Designated as safety issue: No]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 [Time Frame: Week 8 and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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 Frame: Baseline and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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 [Time Frame: Baseline and Week 12] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Official TitlePhase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
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.
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition
  • Pain
  • Diabetic Neuropathies
  • Neuralgia
  • Postherpetic Neuralgia
InterventionDrug: Tapentadol
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.
Other Names:
JNS024ERDrug: Placebo
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Study Arm (s)
  • Experimental: Tapentadol
    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.
  • Placebo Comparator: Placebo
    Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment91
Estimated Completion DateApril 2011
Estimated Primary Completion DateApril 2011
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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesJapan

Administrative Information[ + expand ][ + ]

NCT Number NCT01124617
Other Study ID NumbersCR017002
Has Data Monitoring CommitteeNo
Information Provided ByJanssen Pharmaceutical K.K.
Study SponsorJanssen Pharmaceutical K.K.
CollaboratorsNot Provided
Investigators Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
Verification DateDecember 2013

Locations[ + expand ][ + ]

Japan
Chigasaki, Japan
Japan
Chuo-Ku, Japan
Japan
Fukuoka, Japan
Japan
Inashiki, Japan
Japan
Isesaki, Japan
Japan
Izumisano, Japan
Japan
Kanuma, Japan
Japan
Katsushika-Ku, Japan
Japan
Kawaguchi, Japan
Japan
Kooriyama, Japan
Japan
Kurume, Japan
Japan
Kyoto, Japan
Japan
Matsue, Japan
Japan
Matsumoto, Japan
Japan
Minato-Ku, Japan
Japan
Mitaka, Japan
Japan
Nagano, Japan
Japan
Nagoya, Japan
Japan
Nagoya-City, Japan
Japan
Obihiro, Japan
Japan
Ohta-Ku, Japan
Japan
Ohtsu, Japan
Japan
Okayama, Japan
Japan
Omuta, Japan
Japan
Osaka, Japan
Japan
Sapporo, Japan
Japan
Sendai, Japan
Japan
Setagaya, Japan
Japan
Shimotsuga, Japan
Japan
Tokyo, Japan
Japan
Ube, Japan
Japan
Yokohama, Japan