Long-term Open-Label Safety Study to Evaluate EN3409

Completed · Phase 3

Conditions studied: Low Back Pain, Osteoarthritis, Neuropathic Pain

In brief

The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

Key facts

Study ID

NCT01755546

Run by

BioDelivery Sciences International

People needed

304

Starts

2012-12-01

Expected to finish

2014-11-01

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
• Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
• De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
• De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
• Stable health, as determined by the Principal Investigator
• Subject is willing and able to comply with all protocol required visits and assessments
• Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study

You may not qualify if…

• A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
• Females who are pregnant, breastfeeding, or plan to become pregnant during the study
• Current cancer-related pain or received chemotherapy within 6 months of screening
• Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of screening
• De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per day within 28 days of screening
• Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
• Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
• History of allergy or contraindications to any opioid or acetaminophen
• Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28 days of screening
• Hypokalemia or clinically unstable cardiac disease
• Moderate to severe hepatic impairment
• Moderate to severe renal impairment
• Current or past history of alcohol or substance
• Positive urine toxicology screen for drugs of abuse
• History of abnormalities on physical exam, vital signs, ECG, or lab values

Where it is running

• Horizon Research Group, Inc — Mobile, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Global Research, LLC — Anaheim, California, United States
• Synergy Clinical Research Center of Escondido — Escondido, California, United States
• RX Clinical Research, Inc. — Garden Grove, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Adam D. Karns, MD — Los Angeles, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Century Clinical Research, Inc. — Daytona Beach, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Florida Health Center — Fort Lauderdale, Florida, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• Southeast Clinical Research, LLC — Jacksonville, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Research Centers of America, LLC — Oakland Park, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Ribo Research LLC DBA Peninsula Research — Ormond Beach, Florida, United States
• Gold Coast Research, LLC — Plantation, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• National Pain Research Institute, LLC — Winter Park, Florida, United States
• River Birch Research Alliance, LLC — Blue Ridge, Georgia, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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