Clinical trial NCT01124617: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Diabetic Neuropathies
Neuralgia
Postherpetic Neuralgia
Keywords: Chronic pain
Diabetic Neuropathic Pain
Neuralgia, Postherpetic
Tapentadol hydrochloride extended-release
JNS024ER
Placebo
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
measure: Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)
timeFrame: Week 12
measure: Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
timeFrame: Week 8 and Week 12
measure: Number of Participants With Categorical Scores on Physician's Global Assessment Scale
timeFrame: Week 8 and Week 12
measure: Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
timeFrame: Baseline and Week 12
measure: Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
timeFrame: Baseline and Week 12
measure: Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Awakenings Based on Sleep Questionnaire
timeFrame: Baseline and Week 12
measure: Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: