Conditions: Pain Diabetic Neuropathies Neuralgia Postherpetic Neuralgia
Keywords: Chronic pain Diabetic Neuropathic Pain Neuralgia, Postherpetic Tapentadol hydrochloride extended-release JNS024ER Placebo
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

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.

Arms:
arm 1: 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 2: Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.

Interventions: intervention 1: Tapentadol intervention 2: Placebo
Intervention descriptions: intervention 1: 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 2: Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.

Protocol document: