The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the treatment of moderate to severe neuropathic pain in patients with a diagnosis of postherpetic neuralgia and post-traumatic neuralgia.
The current study is a randomized (study drug assigned by chance), double-blind (neither the study doctor nor the patient knows the name of the assigned drug), placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and tolerability of JNJ-42160443 in patients with postherpetic neuralgia and post-traumatic neuralgia, followed by a double blind extension and an open-label (study doctor and patient knows the name of the study drug) extension. This study will evaluate the safety and effectiveness of JNJ-42160443 in the treatment of patients with moderate to severe, chronic, neuropathic pain that is not controlled with or without standard pain therapy and who have a diagnosis of postherpetic neuralgia (PHN) or post-traumatic neuralgia. The total duration of the study will be approximately 130 weeks (i.e., includes screening phase, 12-week double-blind efficacy phase, double-blind safety extension phase, and the open-label safety extension phase). During the 12 week treatment and 40 week double-blind extension phases, PHN patients will receive Placebo, JNJ 42160443 1, 3, or 10 mg and post-traumatic neuralgia patients will receive placebo or JNJ-42160443 10 mg; all doses will be given as a single, subcutaneous (under the skin) (SC) injection every 28 days. During the 52-week open-label extension phase, all patients will receive a single SC injection of JNJ-42160443 up to 10 mg every 4, 8, or 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Type=exact number, unit=mg, number= 1, 3, or 10, form=solution for injection, route=Subcutaneous use. One injection of 1, 3, or 10 mg of JNJ-42160443 every 28 days for up to 52 wks and then every 4, 8, or 12 weeks for up to an additional 52 weeks
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks
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Tucson, Arizona, United States
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Fresno, California, United States
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Redondo Beach, California, United States
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Roseville, California, United States
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Hollywood, Florida, United States
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The daily evening assessment of average pain intensity
Time frame: Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase
Pain at its worst
Time frame: Daily for 12 weeks
Brief Pain Inventory
Time frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Neuropathic pain symptom inventory
Time frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Patient Global Impression of Change
Time frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
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Oldsmar, Florida, United States
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Palm Beach Gardens, Florida, United States
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Port Orange, Florida, United States
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St. Petersburg, Florida, United States
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Sunrise, Florida, United States
...and 38 more locations