Clinical trial NCT00993018: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Neuropathy
Keywords: Diabetic Neuropathy
Diabetic painful neuropathy
JNJ-42160443
Neuropathic pain
Pain
Pharmacokinetics
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average pain intensity
timeFrame: Baseline to Week 13
Secondary outcomes:
measure: Pain at its worst
timeFrame: Baseline to Week 13
measure: Brief Pain Inventory
timeFrame: Up to Week 105
measure: Neuropathic pain symptom inventory (NPSI)
timeFrame: Up to Week 105
measure: Patient Global Impression of Change (PGIC)
timeFrame: Up to week 105
measure: Number of patients with adverse events
timeFrame: Up to week 105 and 26 weeks after the last dose of study medication
Other outcomes:
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: Tustin
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Albany
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Winston Salem
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Tullahoma
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Renton
country: United States
state: Washington
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical Trial
role: STUDY_DIRECTOR
References: