Long-term Open-Label Safety Study to Evaluate EN3409

Phase 3

Completed

• Conditions: Low Back Pain; Osteoarthritis; Neuropathic Pain
• Interventions: Drug: EN3409

• Registration Number: NCT01755546
• Lead Sponsor: BioDelivery Sciences International

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-24
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2018-03
• Results First Submitted: 2018-03-16
• Results First Submitted QC: 2018-08-06
• Results First Posted: 2018-09-12
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EN3409	EN3409	Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score	48 weeks	The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.

Trial Locations

Locations (56)

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

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.; 🇺🇸 Tampa, Florida, United States

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