- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041859
A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
August 29, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized-Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability of Tapentadol Extended-Release (ER) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized-withdrawal (only patients that have an initial response to tapentadol are assigned to either tapentadol or placebo), placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of orally administered tapentadol, using the extended release tamper-resistant formulation (TRF), at dosages of 100 to 250 mg twice daily in patients with moderate to severe pain due to chronic, painful DPN.
The study consists of 1) an open-label (all people involved know the identity of the intervention) phase, including a 13-day screening period, a 5-day washout period (where patients are to stop taking their pain medication), a 3-day pre-titration pain-intensity evaluation period (where patients will record their pain intensity twice daily in the morning and evening), and a 3-week, open-label titration period (all patients receive tapentadol study drug), 2) a 12-week, double-blind (neither physician nor patient knows the name of the assigned drug) maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days.
The study will evaluate the effectiveness of orally administered tapentadol ER versus placebo in reducing patients' pain intensity.
The pain intensity will be assessed by comparing the baseline pain level to the level at week 12 of the maintenance phase.
The total duration of study drug treatment for each patient will be approximately 15 weeks.
Safety and tolerability will be evaluated by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), standardized neurologic examinations, and monitoring of adverse events.
Patients will be titrated on tapentadol ER from a starting dose of 50 mg twice daily to the patient's optimal dose ranging between 100 mg and 250 mg twice a day, or placebo.
All doses of study medication will be taken orally with approximately 120 ml of water with or without food for a maximum timeframe of 15 weeks.
Study Type
Interventional
Enrollment (Actual)
460
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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Kelowna, British Columbia, Canada
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Ontario
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Barrie, 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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Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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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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Alabama
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Mobile, Alabama, United States
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Arizona
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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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California
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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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Colorado
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Denver, Colorado, United States
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Florida
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Clearwater, Florida, United States
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Hallandale Beach, 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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Georgia
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Idaho
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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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Indiana
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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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Kansas
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Prairie Village, Kansas, United States
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Louisiana
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Shreveport, Louisiana, United States
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Maryland
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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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Massachusetts
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Brockton, Massachusetts, United States
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Minnesota
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Edina, Minnesota, United States
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Missouri
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Saint Louis, Missouri, United States
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New York
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Cedarhurst, New York, United States
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Flushing, New York, United States
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Ny, 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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North Carolina
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Hickory, North Carolina, United States
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Ohio
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Oregon
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Medford, Oregon, United States
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Pennsylvania
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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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South Carolina
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Texas
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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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Utah
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Salt Lake City, Utah, United States
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Virginia
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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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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Form= tablet, route= oral use.
Matching placebo twice daily.
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Experimental: Tapentadol Extended Release (ER)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)
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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".
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Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)
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The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating "no pain" and a score of 10 indicating "pain as bad as you can imagine".
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Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)
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Distribution of Patient Global Impression of Change at Week 12 Endpoint
Time Frame: End of Double-Blind Treatment at 12 Weeks
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Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is 'very much improved' and 7 is 'very much worse'
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End of Double-Blind Treatment at 12 Weeks
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Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint
Time Frame: Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)
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The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function.
It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine.
The pain intensity subscale score is defined as the mean of the scores from these 4 items.
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Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)
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Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint
Time Frame: Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks
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EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems.
The health state index is a weighted combination of the 5 items.
It has a range of 0 to 1, with 0=deceased and 1=full health.
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Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
December 30, 2009
First Submitted That Met QC Criteria
December 30, 2009
First Posted (Estimate)
January 1, 2010
Study Record Updates
Last Update Posted (Estimate)
September 11, 2013
Last Update Submitted That Met QC Criteria
August 29, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Tapentadol
Other Study ID Numbers
- CR016051
- R331333PAI3027 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
- KF56 (Other Identifier: Grunenthal GmbH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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