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)

This study has been terminated.
(Business decision)
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01063868
First received: February 4, 2010
Last updated: January 30, 2014
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathy, Painful
Diabetic Polyneuropathy
Drug: Tapentadol extended release (ER)
Drug: Oxycodone controlled release (CR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Number of Subjects With Treatment-emergent Adverse Events (TEAE) [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 47
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Drug: Tapentadol extended release (ER)
100, 150, 200, 250 mg twice daily for 52 weeks
Active Comparator: 002
Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Drug: Oxycodone controlled release (CR)
20, 30, 40, 50 mg twice daily for 52 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063868

  Hide Study Locations
Locations
United States, Arizona
Mesa, Arizona, United States
Tucson, Arizona, United States
United States, Florida
Fruitland Park, Florida, United States
New Port Richey, Florida, United States
Oviedo, Florida, United States
Tampa, Florida, United States
United States, Illinois
Libertyville, Illinois, United States
United States, Indiana
Franklin, Indiana, United States
United States, Kentucky
Paducah, Kentucky, United States
United States, Massachusetts
Wellesley Hills, Massachusetts, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
New York, New York, United States
United States, North Carolina
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
United States, Ohio
Kettering, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Virginia Beach, Virginia, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01063868     History of Changes
Other Study ID Numbers: CR016978, R331333PAI3028, KF57
Study First Received: February 4, 2010
Results First Received: April 14, 2011
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Diabetic neuropathy
Painful
Polyneuropathy
Peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Pain
Diabetic Neuropathies
Polyneuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014