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

NCT ID: NCT01124617

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-04-30

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.

Conditions

Pain; Diabetic Neuropathies; Neuralgia; Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tapentadol

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Other Intervention Names

JNS024ER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Chigasaki, , Japan

Chūōku, , Japan

Fukuoka, , Japan

Inashiki, , Japan

Isesaki, , Japan

Izumisano, , Japan

Kanuma, , Japan

Katsushika-ku, , Japan

Kawaguchi, , Japan

kooriyama, , Japan

Kurume, , Japan

Kyoto, , Japan

Matsue, , Japan

Matsumoto, , Japan

Minatoku, , Japan

Mitaka, , Japan

Nagano, , Japan

Nagoya, , Japan

Obihiro, , Japan

Ohta-Ku, , Japan

Ohtsu, , Japan

Okayama, , Japan

Omuta, , Japan

Osaka, , Japan

Sapporo, , Japan

Sendai, , Japan

Setagaya City, , Japan

Shimotsuga, , Japan

Tokyo, , Japan

Ube, , Japan

Yokohama, , Japan

Countries

Japan

Other Identifiers

JNS024ER-JPN-N22

Identifier Type: -

Identifier Source: secondary_id

CR017002

Identifier Type: -

Identifier Source: org_study_id