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

NCT01124617 | Completed Phase 2 Results

• 2 other identifiers: CR017002JNS024ER-JPN-N22
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 31

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).

Conditions

Pain; Diabetic Neuropathies; Neuralgia; Postherpetic Neuralgia

Keywords

Chronic pain; Diabetic Neuropathic Pain; Neuralgia, Postherpetic; Tapentadol hydrochloride extended-release; JNS024ER; Placebo

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (12)

• Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

• Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)

  Week 12

• Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale

  Week 8 and Week 12

• Number of Participants With Categorical Scores on Physician's Global Assessment Scale

  Week 8 and Week 12

• Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale

  Baseline and Week 12

Study Arms (2)

Tapentadol

EXPERIMENTAL

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.

Drug: Tapentadol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tapentadol 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.

Also known as: JNS024ER

Tapentadol

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (31)

Unknown Facility

Chigasaki, Japan

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Chūōku, Japan

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Fukuoka, Japan

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Inashiki, Japan

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Isesaki, Japan

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Izumisano, Japan

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Kanuma, Japan

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Katsushika-ku, Japan

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Kawaguchi, Japan

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kooriyama, Japan

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Kurume, Japan

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Kyoto, Japan

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Matsue, Japan

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Matsumoto, Japan

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Minatoku, Japan

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Mitaka, Japan

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Nagano, Japan

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Nagoya, Japan

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Obihiro, Japan

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Ohta-Ku, Japan

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Ohtsu, Japan

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Okayama, Japan

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Omuta, Japan

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Osaka, Japan

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Sapporo, Japan

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Sendai, Japan

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Setagaya City, Japan

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Shimotsuga, Japan

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Tokyo, Japan

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Ube, Japan

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Yokohama, Japan

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MeSH Terms

Conditions

Pain; Diabetic Neuropathies; Neuralgia; Neuralgia, Postherpetic; Chronic Pain

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Manager
• Organization: Neuroscience department, clinical science department, R&D in Janssen Japan, Chiyodaku, Tokyo 101-0065 Japan

+81-3-4411-5509

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: May 17, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 13, 2014
• Results First Posted: June 26, 2013

Record last verified: 2013-12

Locations

JP (31)