A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time

BioDelivery Sciences International56 sites in 1 country304 target enrollmentDecember 2012

ConditionsLow Back Pain Osteoarthritis Neuropathic Pain

InterventionsEN3409

DrugsEN3409

Overview

Phase: Phase 3
Intervention: EN3409
Conditions: Low Back Pain
Sponsor: BioDelivery Sciences International
Enrollment: 304
Locations: 56
Primary Endpoint: Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

November 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BioDelivery Sciences International

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

EN3409

Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily

Intervention: EN3409

Outcomes

Primary Outcomes

Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score

Time Frame: 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.