Back to resultsA Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Primary Purpose
Diabetic Neuropathy, Painful, Diabetic Polyneuropathy
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tapentadol extended release (ER)
Oxycodone controlled release (CR)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful focused on measuring Diabetic neuropathy, Painful, Polyneuropathy, Peripheral neuropathy
Eligibility Criteria
Inclusion Criteria:
- Man or woman aged 18 years or older
- 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 (this control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening)
- 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
- Patients with baseline score for average pain intensity in the previous 24 hours of =>4 on the 11-point numerical rating scale (NRS) at the beginning of the titration period
Exclusion Criteria:
- Significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia, Alzheimer's disease)
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
001
002
Arm Description
Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Outcomes
Primary Outcome Measures
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Secondary Outcome Measures
Full Information
NCT ID
NCT01063868
First Posted
February 4, 2010
Last Updated
January 30, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Grünenthal GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01063868
Brief Title
A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Official Title
A One-Year, Randomized, Open-Label, Parallel-Group, Multiple-Dose Long-Term Safety Study With Controlled Adjustment of Dose of Tapentadol Extended-Release (ER) and Oxycodone Controlled-Release (CR) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Grünenthal GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.
Detailed Description
This is a randomized, open-label, active-controlled, multicenter study evaluating the safety profile 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) a 13-day screening period, a 3-7-day washout period (where patients are to stop taking their pain medication), a 1-day pretitration pain-intensity evaluation period (where patients will record their 24-hour pain intensity), and a 3-week, open-label titration period (patients will receive either tapentadol ER or oxycodone CR study drug in a 3 to 1 ratio), 2) a 49-week, open-label maintenance phase, and 3) a posttreatment phase of approximately 10 to 14 days. The study will evaluate the safety and tolerability of orally administered tapentadol ER by vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECGs), opioid withdrawal scales, assessment of patient-reported constipation, standardized neurologic examinations and monitoring of adverse events. Assessments of pain relief include the pain intensity numerical rating scale, and patient global impression of change scale (PGIC). The total duration of study drug treatment for each patient will be approximately 52 weeks. Titrate tapentadol ER 50 mg twice daily or oxycodone CR 10 mg twice daily to patient's optimal dose ranging between 100 mg and 250 mg twice daily or 20 and 50 mg twice daily, respectively. All doses of study medication will be taken orally with or without food for a maximum timeframe of 52 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful, Diabetic Polyneuropathy
Keywords
Diabetic neuropathy, Painful, Polyneuropathy, Peripheral neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Arm Title
002
Arm Type
Active Comparator
Arm Description
Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Tapentadol extended release (ER)
Intervention Description
100, 150, 200, 250 mg twice daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Oxycodone controlled release (CR)
Intervention Description
20, 30, 40, 50 mg twice daily for 52 weeks
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
Description
The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Time Frame
Entire Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man or woman aged 18 years or older
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 (this control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening)
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
Patients with baseline score for average pain intensity in the previous 24 hours of =>4 on the 11-point numerical rating scale (NRS) at the beginning of the titration period
Exclusion Criteria:
Significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia, Alzheimer's disease)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Fruitland Park
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Oviedo
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Libertyville
State/Province
Illinois
Country
United States
City
Franklin
State/Province
Indiana
Country
United States
City
Paducah
State/Province
Kentucky
Country
United States
City
Wellesley Hills
State/Province
Massachusetts
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Odessa
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Virginia Beach
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
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