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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)

Primary Purpose

Pain, Neuralgia, Postherpetic, Neuralgia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-42160443
Placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Moderate to severe chronic peripheral neuropathic pain, Postherpetic neuralgia, Post-traumatic neuralgia, Moderate to severe chronic pain, JNJ-42160443

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

001

002

Arm Description

JNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days

Placebo SC injection once every 28 days

Outcomes

Primary Outcome Measures

The daily evening assessment of average pain intensity

Secondary Outcome Measures

Pain at its worst
Brief Pain Inventory
Neuropathic pain symptom inventory
Patient Global Impression of Change

Full Information

First Posted
August 21, 2009
Last Updated
March 29, 2016
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00964990
Brief Title
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuralgia, Postherpetic, Neuralgia, Mononeuropathies
Keywords
Moderate to severe chronic peripheral neuropathic pain, Postherpetic neuralgia, Post-traumatic neuralgia, Moderate to severe chronic pain, JNJ-42160443

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
001
Arm Type
Experimental
Arm Description
JNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days
Arm Title
002
Arm Type
Placebo Comparator
Arm Description
Placebo SC injection once every 28 days
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pain at its worst
Time Frame
Daily for 12 weeks
Title
Brief Pain Inventory
Time Frame
Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Title
Neuropathic pain symptom inventory
Time Frame
Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Title
Patient Global Impression of Change
Time Frame
Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Tucson
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Arizona
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United States
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Fresno
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California
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United States
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Redondo Beach
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California
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Roseville
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California
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Hollywood
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Oldsmar
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Palm Beach Gardens
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Port Orange
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St Petersburg
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Sunrise
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Tamarac
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Decatur
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Georgia
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Boise
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Idaho
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Lewiston
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Idaho
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Evansville
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Indiana
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Franklin
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Indiana
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Lexington
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Kentucky
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Shreveport
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Louisiana
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Boston
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Massachusetts
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Brockton
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Hyannis
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Massachusetts
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Ann Arbor
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Saint Louis
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Omaha
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Nebraska
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Meridian
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New Jersey
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Albany
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New York
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Ny
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New York
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Rochester
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New York
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Charlotte
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North Carolina
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United States
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Hickory
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North Carolina
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Allentown
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United States
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Altoona
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Pennsburg
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Philadelphia
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Greer
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South Carolina
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Nashville
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Tennessee
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United States
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Smyrna
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Tennessee
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Dallas
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United States
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Plano
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Texas
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United States
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San Antonio
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Texas
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United States
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Edegem
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Belgium
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Leuven
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Belgium
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Waterschei-Zwartberg
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Belgium
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Alkmaar
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Netherlands
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Maastricht
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Netherlands
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27153360
Citation
Wang H, Romano G, Fedgchin M, Russell L, Sanga P, Kelly KM, Frustaci ME, Thipphawong J. Fulranumab in Patients With Pain Associated With Postherpetic Neuralgia and Postraumatic Neuropathy: Efficacy, Safety, and Tolerability Results From a Randomized, Double-blind, Placebo-controlled, Phase-2 Study. Clin J Pain. 2017 Feb;33(2):99-108. doi: 10.1097/AJP.0000000000000388.
Results Reference
derived

Learn more about this trial

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

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