A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy

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:
NCT00993018
First received: October 8, 2009
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Diabetic Neuropathy
Drug: JNJ-42160443 (1 mg)
Drug: JNJ-42160443 (3 mg)
Drug: JNJ-42160443 (10 mg)
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 Diabetic Painful Neuropathy, 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:
  • Average pain intensity [ Time Frame: Baseline to Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 105 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to Week 105 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to week 105 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to week 105 and 26 weeks after the last dose of study medication ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-42160443 (1 mg)
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.
Drug: JNJ-42160443 (1 mg)
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.
Experimental: JNJ-42160443 (3 mg)
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.
Drug: JNJ-42160443 (3 mg)
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.
Experimental: JNJ-42160443 (10 mg)
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.
Drug: JNJ-42160443 (10 mg)
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 Comparator: Placebo
Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.
Drug: Placebo
Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993018

Locations
United States, Arkansas
Jonesboro, Arkansas, United States
United States, California
Fresno, California, United States
La Jolla, California, United States
Long Beach, California, United States
Redondo Beach, California, United States
Tustin, California, United States
Walnut Creek, California, United States
United States, Florida
Bradenton, Florida, United States
Palm Beach Gardens, Florida, United States
United States, Maryland
Baltimore, Maryland, United States
United States, New York
Albany, New York, United States
Syracuse, New York, United States
United States, North Carolina
Winston Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Tennessee
Tullahoma, Tennessee, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
United States, Washington
Renton, Washington, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and 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: NCT00993018     History of Changes
Other Study ID Numbers: CR016438, 42160443NPP2002, 2008-007676-13
Study First Received: October 8, 2009
Last Updated: March 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Diabetic Neuropathy
Diabetic painful neuropathy
JNJ-42160443
Neuropathic pain
Pain
Pharmacokinetics

Additional relevant MeSH terms:
Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 23, 2014