A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

NCT01041859 | Completed Phase 3 Results

• 3 other identifiers: CR016051R331333PAI3027KF56
• Study Type: interventional
• Target: 460
• Locations: 3 countries
• Sites: 72

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who tolerated tapentadol (ER) and have an initial treatment effect (pain improvement) after a 3-week, open-label titration period.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Painful; Polyneuropathy; Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12

  For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

  Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)

Secondary Outcomes (4)

• Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint

  Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)

• Distribution of Patient Global Impression of Change at Week 12 Endpoint

  End of Double-Blind Treatment at 12 Weeks

• Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint

  Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)

• Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint

  Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks

Study Arms (2)

Tapentadol Extended Release (ER)

EXPERIMENTAL

Drug: Tapentadol extended release (ER)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tapentadol extended release (ER) DRUG

Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.

Tapentadol Extended Release (ER)

Placebo DRUG

Form= tablet, route= oral use. Matching placebo twice daily.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with Type 1 or 2 diabetes mellitus must have a documented clinical diagnosis of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening
• Diagnosis must include pain plus reduction or absence of pin sensibility and/or vibration sensibility on Total Neuropathy Score - Nurse (TNSn) examination in lower and/or upper extremities at screening
• The investigator considers the patient's blood glucose to be controlled by diet, or hypoglycemics, or insulin for at least 3 months prior to enrolling in the study
• Patients have been taking analgesic medications for the condition for at least 3 months prior to screening (patients taking opioid analgesics must be dissatisfied with current treatment, and patients taking non-opioid analgesics must be dissatisfied with current analgesia)
• Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to \<=160mg of oral morphine

You may not qualify if:

• Significant history of pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia)
• History of moderate to severe hepatic impairment
• Severely impaired renal function
• Clinically significant laboratory abnormalities
• Clinically significant cardiac disease
• History of seizure disorder or epilepsy
• History of any other clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise patient safety during study participation

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Grünenthal GmbH: collaborator

Study Sites (72)

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Fresno, California, United States

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Orange, California, United States

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Redding, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Clearwater, Florida, United States

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Hallandale, Florida, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Boise, Idaho, United States

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Eagle, Idaho, United States

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Meridian, Idaho, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Fishers, Indiana, United States

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Prairie Village, Kansas, United States

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Shreveport, Louisiana, United States

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Owings Mills, Maryland, United States

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Pasadena, Maryland, United States

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Rockville, Maryland, United States

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Brockton, Massachusetts, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Cedarhurst, New York, United States

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Flushing, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Valley Stream, New York, United States

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Williamsville, New York, United States

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Hickory, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Medford, Oregon, United States

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Allentown, Pennsylvania, United States

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Altoona, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Anderson, South Carolina, United States

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Greer, South Carolina, United States

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Bulverde, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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Schertz, Texas, United States

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Salt Lake City, Utah, United States

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Alexandria, Virginia, United States

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Norfolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Calgary, Alberta, Canada

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Kelowna, British Columbia, Canada

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Barrie, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Hawkesbury, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Dollard-des-Ormeaux, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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San Juan, Puerto Rico

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MeSH Terms

Conditions

Pain; Polyneuropathies; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director, Clinical Leader
• Organization: Janssen Research&Development

609-730-6777

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: December 30, 2009
• First Posted: January 1, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 11, 2013
• Results First Posted: May 14, 2012

Record last verified: 2013-08

Locations

CA (11); PR (1); US (60)