Status:
TERMINATED
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the analgesic efficacy, safety and tolerability of multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28 days to patien...
Detailed Description
This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither investigator nor the patient knows the treatment that the pati...
Eligibility Criteria
Inclusion
- Chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigator
- Currently taking neuropathic pain medication limited to maximal allowed doses according to guidelines provided, but are not adequately controlled by standard of care
- Currently not taking neuropathic pain medications because they are intolerable to, or not willing to use, standard of care
- Mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days on an 11-point numerical rating scale
- Pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus
- Required to have stable glycemic control
Exclusion
- Patients with severe diabetic neuropathy defined by severe autonomic dysfunction or blood pressure instability Separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their diagnosis of Diabetic Peripheral Neuropathy
- Patients with evidence of another neuropathic pain not under the study, such as pain resulting from post-traumatic neuralgia, post-surgical neuropathy, complex regional pain, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, Human Immunodeficiency Virus (HIV) infection
- Major surgeries, trauma, and non-healing wounds/ulcers within 3 months prior to study medication
- History of severe traumatic brain injury within the past 15 years
- Other peripheral neuropathy, parasthesia or dyesthesia or previously diagnosed neurological condition causing these symptoms not related with diabetic painful neuropathy under study
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00993018
Start Date
November 1 2009
End Date
June 1 2011
Last Update
June 3 2016
Active Locations (23)
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1
Jonesboro, Arkansas, United States
2
Fresno, California, United States
3
La Jolla, California, United States
4
Long Beach, California, United States