An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

NCT01124604 | Completed Phase 2 Results

• 2 other identifiers: CR016999JNS024ER-JPN-N21
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.

Conditions

Pain; Low Back Pain; Back Pain; Osteoarthritis, Knee

Keywords

Pain; Low Back Pain; Back Pain; Osteoarthritis, Knee; Tapentadol; Tapentadol Hydrochloride Extended Release

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12

  Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.

  Baseline, Week 12

Secondary Outcomes (14)

• Change From Baseline in 11-point Numerical Rating Scale (NRS)

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

• Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)

  Week 12

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

  Week 8, Week 12

• Number of Participants With Response Based on Physician's Global Assessment Scale

  Week 8, Week 12

• Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale

  Baseline, Week 12

Other Outcomes (2)

• Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)

  Week 12

• Serum Concentration of Tapentadol

  Week 2, 4, 8, 12

Study Arms (2)

Tapentadol Hydrochloride

EXPERIMENTAL

Drug: Tapentadol Hydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tapentadol Hydrochloride DRUG

Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.

Tapentadol Hydrochloride

Placebo DRUG

Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.

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 osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
• Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
• Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
• Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
• Participants who are able to visit the medical institutions throughout the study period

You may not qualify if:

• Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
• Participants with current or a history of epilepsy or seizure disorders
• Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
• Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
• Participants with moderate to severe liver dysfunction or severe renal dysfunction

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (19)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Amagasaki, Japan

Location

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Chiba, Japan

Location

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Chikushi, Japan

Location

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Edogawa City, Japan

Location

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Fukuoka, Japan

Location

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Fukushima, Japan

Location

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Hiratsuka, Japan

Location

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Kawasaki, Japan

Location

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Kōtō City, Japan

Location

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Matsudo, Japan

Location

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Meguro City, Japan

Location

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Minatoku, Japan

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Niigata, Japan

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Osaka, Japan

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Sagamihara, Japan

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Unknown Facility

Shibuya City, Japan

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Unknown Facility

Shinjuku-Ku, Japan

Location

Unknown Facility

Toshima-Ku, Japan

Location

MeSH Terms

Conditions

Pain; Low Back Pain; Back Pain; Osteoarthritis, Knee

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic 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. 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 14, 2013
• Results First Posted: April 17, 2013

Record last verified: 2013-05

Locations

JP (19)