Clinical Trial: A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-trau

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: 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 ]

Original Primary Outcome: The primary outcome measure is 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 ]

Current Secondary Outcome:

  • 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) ]


Original Secondary Outcome:

  • Pain at its worst [ Time Frame: Daily for 12 weeks ]
  • Brief Pain Inventory [ Time Frame: Visit 1, 3, 7, 8, 9 ]
  • Neuropathic pain symptom inventory [ Time Frame: Visit 1, 3, 7, 8, 9 ]
  • Patient Global Impression of Change [ Time Frame: Visit 7, 8,9 ]


Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: August 21, 2009
Date Started: September 2009
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016