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Long-term Open-Label Safety Study to Evaluate EN3409

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ClinicalTrials.gov Identifier: NCT01755546
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : September 12, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Osteoarthritis Neuropathic Pain Drug: EN3409 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: EN3409
Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
 Drug: EN3409
Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily
Other Name: Buprenorphine HCI Buccal Film 300-900 mcg twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755546


Locations
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Sponsors and Collaborators
BioDelivery Sciences International
Investigators
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Study Director: Andrew Finn, PharmD BioDelivary Sciences Internantional, Inc.
More Information
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Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT01755546    
Other Study ID Numbers: EN3409-309
First Posted: December 24, 2012    Key Record Dates
Results First Posted: September 12, 2018
Last Update Posted: October 18, 2018
Last Verified: March 2018
Keywords provided by BioDelivery Sciences International:
Chronic Pain
CLBP
Chronic Low Back Pain
Back Pain
Osteoarthritis
 OA
Neuropathic Pain
Nerve pain
Painful neuropathy
Additional relevant MeSH terms:
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Osteoarthritis
Neuralgia
Back Pain
Low Back Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists