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

This study has been terminated.
(Logistic reasons associated with the FDA-imposed clinical hold.)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00964990
First received: August 21, 2009
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Pain
Neuralgia, Postherpetic
Neuralgia
Mononeuropathies
Drug: JNJ-42160443
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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-traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-label Safety Extension

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at its worst [ Time Frame: Daily for 12 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory [ Time Frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9) ] [ Designated as safety issue: No ]
  • Neuropathic pain symptom inventory [ Time Frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9) ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9) ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
JNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days
Drug: JNJ-42160443
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
Placebo Comparator: 002
Placebo SC injection once every 28 days
Drug: Placebo
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients diagnosed with postherpetic neuralgia or post-traumatic neuralgia and who have chronic neuropathic pain (pain persistent for > 6 months) that is moderate to severe; Currently taking pain medication but are not adequately controlled by standard of care or are not currently taking pain medications because intolerable to, or not willing to use, standard of care. Exclusion Criteria: History of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia

  • Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I
  • Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury
  • Patient whose nerve injury or pain is expected to recover in the next 4 months
  • Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection
  • Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study
  • Women who are pregnantHistory of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia; Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I; Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury; Patient whose nerve injury or pain is expected to recover in the next 4 months; Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection; Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study; Women who are pregnant or breast-feeding; Type I or Type II diabetes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964990

  Show 48 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00964990     History of Changes
Other Study ID Numbers: CR016474, 42160443NPP2001, 2008-007478-39
Study First Received: August 21, 2009
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
United States: Federal Government

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Moderate to severe chronic peripheral neuropathic pain
Postherpetic neuralgia
Post-traumatic neuralgia
Moderate to severe chronic pain
JNJ-42160443

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Mononeuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014