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

NCT00993018 | Terminated Phase 2 DMC

• 3 other identifiers: CR01643842160443NPP20022008-007676-13
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 23

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).

Conditions

Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Diabetic painful neuropathy; JNJ-42160443; Neuropathic pain; Pain; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 13

Secondary Outcomes (5)

• Pain at its worst

  Baseline to Week 13

• Brief Pain Inventory

  Up to Week 105

• Neuropathic pain symptom inventory (NPSI)

  Up to Week 105

• Patient Global Impression of Change (PGIC)

  Up to week 105

• Number of patients with adverse events

  Up to week 105 and 26 weeks after the last dose of study medication

Study Arms (4)

JNJ-42160443 (1 mg)

EXPERIMENTAL

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 (3 mg)

EXPERIMENTAL

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 (10 mg)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.

Drug: Placebo

Interventions

JNJ-42160443 (1 mg) DRUG

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 (1 mg)

JNJ-42160443 (3 mg) DRUG

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 (3 mg)

JNJ-42160443 (10 mg) DRUG

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.

JNJ-42160443 (10 mg)

Placebo DRUG

Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (23)

Unknown Facility

Jonesboro, Arkansas, United States

Location

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Redondo Beach, California, United States

Location

Unknown Facility

Tustin, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Palm Beach Gardens, Florida, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Tulsa, Oklahoma, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Greer, South Carolina, United States

Location

Unknown Facility

Tullahoma, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Renton, Washington, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Pain

Interventions

fulranumab

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 3, 2016

Record last verified: 2016-05

Locations

US (23)