Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Open-Label Safety Study to Evaluate EN3409

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE December 24, 2012
Results First Submitted Date  ICMJE March 16, 2018
Results First Posted Date  ICMJE September 12, 2018
Last Update Posted Date October 18, 2018
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
To determine the long-term safety and tolerability of BEMA Buprenorphine (dosed every 12 hours [Q12h]) in subjects with moderate to severe chronic pain (CP) requiring continuous around-the-clock (ATC) opioid analgesia for an extended period of time [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Open-Label Safety Study to Evaluate EN3409
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Osteoarthritis
  • Neuropathic Pain
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: EN3409
Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
Intervention: Drug: EN3409
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2018)
304
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2012)
200
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755546
Other Study ID Numbers  ICMJE EN3409-309
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioDelivery Sciences International
Study Sponsor  ICMJE BioDelivery Sciences International
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Finn, PharmD BioDelivary Sciences Internantional, Inc.
PRS Account BioDelivery Sciences International
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP