JNJ Inclusion/Exclusion Print E-mail

Johnson and Johnson Pharmaceutical Research & Development

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Diabetic Painful Neuropathy, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Man or woman between 81 and 80 years of age
  2. Subjects who have chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigator and are either currently taking pain medication but are not adequately controlled by standard of care (which may include antidepressants, antiepileptics, topical lidocaine, or opiods), or are not currently taking pain medications because they are intolerable to, or not willing to use, standard of care

Maximal Neuropathic Pain Medication Allowed: Use of two or less of the following medications, each one from a different class, is permitted:

  • Anticonvulsants: gabapentin (< 1800 mg/day) or pregabalin (< 300 mg/day)
  • Opioid analgesics (< 60 mg/day oxycodone equivalent) or tramadol (< 200 mg/day)
  • Antidepressants: tricyclic antidepressants (< 75 mg/day amitriptyline equivalent), duloxetine (< 60 mg/day), or venlafaxine (< 150 mg/day)
  1. Subjects must have a mean average pain intensity score of at least 5 out of 10
  2. Subjects must have pain (symmetrical in the feet for greater than 6 months) due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus
  3. Subjects who are sexually active must consent to utilize a medically acceptable and highly effective method of contraception throughout the entire study from screening through 6 months after the last dose of study drug
  4. Negative urine drug screen (including tetrahydrocannabinol (THC), cocaine, and heroin)
  5. No active or chronic hepatitis due to hepatitis B infection
  6. Negative for anti-hepatitis C virus antibody (anti-HCV)
  7. Subject has access to a touchtone phone

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. History of a separate pain condition that is more severe than their pain due to diabetic neuropathy or pain resulting from postherpetic neuralgia, post-traumatic neuralgia, post-surgical neuropathy, complex regional pain, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection
  2. Major surgeries, trauma, and nonhealing wounds/ulcers within 3 months prior to study drug
  3. History of seizure within 1 year, or severe traumatic brain injury within the past 15 years
  4. History of epilepsy or multiple sclerosis
  5. History of malignancy (within the past 5 years) or current malignancy with the exception of basal cell carcinoma that has been treated and is no longer present
  6. Received an investigational drug or an investigational medical device within 30 days before the planned start of treatment or are currently enrolled in an investigational study
  7. History of ocular herpes simplex, HSV pneumonia, or HSV encephalitis
  8. Currently receiving chronic systemic immunosuppressive therapy
  9. Participation in an analgesia trail within 90 days of the first planned dose of study drug
  10. Women who are pregnant or breast-feeding
  11. Significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric or immunological disturbances
  12. HbA1c  > 11.0%
  13. Active, major depression or generalized anxiety disorder that has not been controlled 3 months prior to screening
  14. Clinical diagnosis of human immunodeficiency virus (HIV) infection or clinical diagnosis of acquired immunodeficiency syndrome (AIDS) or any immune deficiency
  15. Subject who consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcohol beverages per day on a regular basis
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