Long-term Open-Label Safety Study to Evaluate EN3409

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755546
• Other study ID #: EN3409-309
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2018
• Source: BioDelivery Sciences International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Neuralgia
• Neuropathic Pain
• Osteoarthritis

Intervention

Drug:
• EN3409
Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily

Locations

Country	Name	City	State
United States	Global Research, LLC	Anaheim	California
United States	FutureSearch Clinical Trials	Austin	Texas
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Clinical Inquest Center, Ltd	Beavercreek	Ohio
United States	The Center for Clinical Trials	Biloxi	Mississippi
United States	Parkway Medical Center	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Willis-Knighton Physician Network	Bossier City	Louisiana
United States	Cadillac Clinical Research	Cadillac	Michigan
United States	Pain Specialists of Charleston, P.A.	Charleston	South Carolina
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	KRK Medical Research	Dallas	Texas
United States	Century Clinical Research, Inc.	Daytona Beach	Florida
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Synergy Clinical Research Center of Escondido	Escondido	California
United States	Global Scientific Innovations	Evansville	Indiana
United States	New England Center for Clinical Research, Inc.	Fall River	Massachusetts
United States	Plains Medical Clinic, LLC	Fargo	North Dakota
United States	Florida Health Center	Fort Lauderdale	Florida
United States	Prestige Clinical Research	Franklin	Ohio
United States	RX Clinical Research, Inc.	Garden Grove	California
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Eastern Research, Inc.	Hialeah	Florida
United States	Advanced Clinical Research of Houston	Houston	Texas
United States	Southeast Clinical Research, LLC	Jacksonville	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Clinical Investigations Specialist, Inc.	Kenosha	Wisconsin
United States	Long Beach Center for Clinical Research	Long Beach	California
United States	Adam D. Karns, MD	Los Angeles	California
United States	Drug Studies America	Marietta	Georgia
United States	Taylor Research, LLC	Marietta	Georgia
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Horizon Research Group, Inc	Mobile	Alabama
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	In-Quest Medical Research, LLC	Norcross	Georgia
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	Arizona Research Center	Phoenix	Arizona
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Innovative Clinical Trials	San Antonio	Texas
United States	River Cities Clinical Research Center	Shreveport	Louisiana
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Optimed Research, Ltd.	Tiffin	Ohio
United States	Integrated Clinical Trials Services, Inc.	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	National Pain Research Institute, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BioDelivery Sciences International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score	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.	48 weeks