Back to resultsA Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
Primary Purpose
Diabetic Neuropathy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-42160443 (1 mg)
JNJ-42160443 (3 mg)
JNJ-42160443 (10 mg)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Diabetic Neuropathy, Diabetic painful neuropathy, JNJ-42160443, Neuropathic pain, Pain, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigator
- Currently taking neuropathic pain medication limited to maximal allowed doses according to guidelines provided, but are not adequately controlled by standard of care
- Currently not taking neuropathic pain medications because they are intolerable to, or not willing to use, standard of care
- Mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days on an 11-point numerical rating scale
- Pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus
- Required to have stable glycemic control
Exclusion Criteria:
- Patients with severe diabetic neuropathy defined by severe autonomic dysfunction or blood pressure instability Separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their diagnosis of Diabetic Peripheral Neuropathy
- Patients with evidence of another neuropathic pain not under the study, such as pain resulting from post-traumatic neuralgia, post-surgical neuropathy, complex regional pain, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, Human Immunodeficiency Virus (HIV) infection
- Major surgeries, trauma, and non-healing wounds/ulcers within 3 months prior to study medication
- History of severe traumatic brain injury within the past 15 years
- Other peripheral neuropathy, parasthesia or dyesthesia or previously diagnosed neurological condition causing these symptoms not related with diabetic painful neuropathy under study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
JNJ-42160443 (1 mg)
JNJ-42160443 (3 mg)
JNJ-42160443 (10 mg)
Placebo
Arm Description
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.
Outcomes
Primary Outcome Measures
Average pain intensity
The mean of the daily evening assessment of average pain intensity is measured by using 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Secondary Outcome Measures
Pain at its worst
The assessment of pain at its worst in the past 24 hours will be performed once daily, in the evening, using an 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Brief Pain Inventory
The Brief Pain Inventory short form (BPI-SF) includes 4 items assessing pain intensity (pain intensity subscales) and 7 items assessing how much pain has interfered with daily activities (pain interference subscales). The intensity of pain is assessed with 4 items using an 11-point NRS from 0 = no pain to 10 = higher severity of pain. This assessment will be conducted on daily basis.
Neuropathic pain symptom inventory (NPSI)
The NPSI contains 12 questions designed to evaluate the different symptoms of neuropathic pain. The questions make up the following 5 subscales: burning (superficial) spontaneous pain, pressing (deep) spontaneous pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia. Subscale scores can be derived from averaging the scores from the item scores that make up the subscales, ranging from 0 to 10. A total intensity score is the sum of the subscale scores, ranging from 0 to 100. Higher scores indicate worse pain. This assessment will be conducted on daily basis.
Patient Global Impression of Change (PGIC)
The patient will be asked to rate their change in their neuropathic pain with the following responses: very much improved, much improved, minimally improved, not changed, minimally worse, much worse, or very much worse. This assessment will be conducted on daily basis.
Number of patients with adverse events
Full Information
NCT ID
NCT00993018
First Posted
October 8, 2009
Last Updated
May 9, 2016
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00993018
Brief Title
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
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 Diabetic Painful Neuropathy, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 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 analgesic efficacy, safety and tolerability of multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28 days to patients with diabetic painful neuropathy (a disease condition in diabetic patients that affects all peripheral nerves including pain fibers, motor neurons and the autonomic nervous system).
Detailed Description
This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither investigator nor the patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), dose-ranging study (study carried out at different doses) to evaluate the analgesic efficacy, safety, and tolerability of multiple doses of JNJ-42160443 in patients with neuropathic pain, followed by a double-blind safety extension and an open-label (all people know the identity of the intervention) safety extension. The study will consist of 5 sequential phases: 1) screening, 2) a 12-week double-blind efficacy, 3) a 40-week double-blind safety extension, 4) a 52-week open-label safety extension, and 5) a 26-week post-treatment/follow-up. After the screening phase, patient randomization will be stratified by current pain medication use (patients who are currently using or who are not currently using permitted pain medication). The planned doses for the double-blind efficacy phase and double blind safety extension phase are placebo, JNJ-42160443 1, 3, or 10 mg administered as a single, subcutaneous injection every 28 days. Safety assessment will include adverse events, injection site evaluations, clinical laboratory tests, electrocardiogram, vital signs, physical examinations, neurological examinations, and joint safety which will be monitored throughout the study. The total study duration (including all the 5 phases) will be approximately 131 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Diabetic Neuropathy, Diabetic painful neuropathy, JNJ-42160443, Neuropathic pain, Pain, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-42160443 (1 mg)
Arm Type
Experimental
Arm Description
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Arm Title
JNJ-42160443 (3 mg)
Arm Type
Experimental
Arm Description
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Arm Title
JNJ-42160443 (10 mg)
Arm Type
Experimental
Arm Description
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443 (1 mg)
Intervention Description
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443 (3 mg)
Intervention Description
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443 (10 mg)
Intervention Description
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.
Primary Outcome Measure Information:
Title
Average pain intensity
Description
The mean of the daily evening assessment of average pain intensity is measured by using 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Time Frame
Baseline to Week 13
Secondary Outcome Measure Information:
Title
Pain at its worst
Description
The assessment of pain at its worst in the past 24 hours will be performed once daily, in the evening, using an 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Time Frame
Baseline to Week 13
Title
Brief Pain Inventory
Description
The Brief Pain Inventory short form (BPI-SF) includes 4 items assessing pain intensity (pain intensity subscales) and 7 items assessing how much pain has interfered with daily activities (pain interference subscales). The intensity of pain is assessed with 4 items using an 11-point NRS from 0 = no pain to 10 = higher severity of pain. This assessment will be conducted on daily basis.
Time Frame
Up to Week 105
Title
Neuropathic pain symptom inventory (NPSI)
Description
The NPSI contains 12 questions designed to evaluate the different symptoms of neuropathic pain. The questions make up the following 5 subscales: burning (superficial) spontaneous pain, pressing (deep) spontaneous pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia. Subscale scores can be derived from averaging the scores from the item scores that make up the subscales, ranging from 0 to 10. A total intensity score is the sum of the subscale scores, ranging from 0 to 100. Higher scores indicate worse pain. This assessment will be conducted on daily basis.
Time Frame
Up to Week 105
Title
Patient Global Impression of Change (PGIC)
Description
The patient will be asked to rate their change in their neuropathic pain with the following responses: very much improved, much improved, minimally improved, not changed, minimally worse, much worse, or very much worse. This assessment will be conducted on daily basis.
Time Frame
Up to week 105
Title
Number of patients with adverse events
Time Frame
Up to week 105 and 26 weeks after the last dose of study medication
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:
Chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigator
Currently taking neuropathic pain medication limited to maximal allowed doses according to guidelines provided, but are not adequately controlled by standard of care
Currently not taking neuropathic pain medications because they are intolerable to, or not willing to use, standard of care
Mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days on an 11-point numerical rating scale
Pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus
Required to have stable glycemic control
Exclusion Criteria:
Patients with severe diabetic neuropathy defined by severe autonomic dysfunction or blood pressure instability Separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their diagnosis of Diabetic Peripheral Neuropathy
Patients with evidence of another neuropathic pain not under the study, such as pain resulting from post-traumatic neuralgia, post-surgical neuropathy, complex regional pain, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, Human Immunodeficiency Virus (HIV) infection
Major surgeries, trauma, and non-healing wounds/ulcers within 3 months prior to study medication
History of severe traumatic brain injury within the past 15 years
Other peripheral neuropathy, parasthesia or dyesthesia or previously diagnosed neurological condition causing these symptoms not related with diabetic painful neuropathy under study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Fresno
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Redondo Beach
State/Province
California
Country
United States
City
Tustin
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Palm Beach Gardens
State/Province
Florida
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Tullahoma
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Renton
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
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