A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathy

In brief

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 patients with diabetic painful neuropathy (a disease condition in diabetic patients that affects all peripheral nerves including pain fibers, motor neurons and the autonomic nervous system).

Key facts

Study ID

NCT00993018

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

77

Starts

2009-11-01

Expected to finish

2011-06-01

Last updated by the study team

2016-06-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Redondo Beach, California, United States
• Study site — Tustin, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Albany, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Greer, South Carolina, United States
• Study site — Tullahoma, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Plano, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Renton, Washington, United States

Full record on ClinicalTrials.gov

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