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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00964990
Recruitment Status : Terminated (Logistic reasons associated with the FDA-imposed clinical hold.)
First Posted : August 25, 2009
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Pain Neuralgia, Postherpetic Neuralgia Mononeuropathies Drug: JNJ-42160443 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pain at its worst [ Time Frame: Daily for 12 weeks ]
  2. Brief Pain Inventory [ Time Frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9) ]
  3. Neuropathic pain symptom inventory [ Time Frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9) ]
  4. Patient Global Impression of Change [ Time Frame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964990


Locations
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United States, Arizona
Tucson, Arizona, United States
United States, California
Fresno, California, United States
Redondo Beach, California, United States
Roseville, California, United States
United States, Florida
Hollywood, Florida, United States
Oldsmar, Florida, United States
Palm Beach Gardens, Florida, United States
Port Orange, Florida, United States
St Petersburg, Florida, United States
Sunrise, Florida, United States
Tamarac, Florida, United States
United States, Georgia
Decatur, Georgia, United States
United States, Idaho
Boise, Idaho, United States
Lewiston, Idaho, United States
United States, Indiana
Evansville, Indiana, United States
Franklin, Indiana, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Hyannis, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Jersey
Meridian, New Jersey, United States
United States, New York
Albany, New York, United States
Ny, New York, United States
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Altoona, Pennsylvania, United States
Pennsburg, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
Smyrna, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Belgium
Edegem, Belgium
Leuven, Belgium
Waterschei-Zwartberg, Belgium
Netherlands
Alkmaar, Netherlands
Maastricht, Netherlands
Spain
Barcelona, Spain
Madrid, Spain
Valencia, Spain
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00964990    
Other Study ID Numbers: CR016474
42160443NPP2001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2008-007478-39 ( EudraCT Number )
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: March 2016
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:
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Neuralgia
Neuralgia, Postherpetic
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations