Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
NCT ID: NCT01633944
Last Updated: 2017-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
752 participants
INTERVENTIONAL
2012-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Twice Daily Dosing
Placebo
Matching Placebo Buccal Film twice daily
Buprenorphine HCl Buccal Film
Twice Daily Dosing
Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
Interventions
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Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
Placebo
Matching Placebo Buccal Film twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
* Stable health, as determined by Principal Investigator
* Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
* Willing and able to comply with all protocol required visits and assessments
Exclusion Criteria
* Receiving opioid analgesic medication \>10 mg MSE per day within 28 days of screening
* Subjects with a history of other chronic painful conditions
* Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
* Allergy or contraindications to any opioid or acetaminophen
* Surgical procedure for relief of pain with 6 months
* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
* QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
* History of long QT syndrome or a family member with this condition
* Moderate to severe hepatic impairment
* Moderate to severe renal impairment
* Current or past history of alcohol abuse
* Positive urine toxicology screen for drug of abuse
* History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
18 Years
ALL
No
Sponsors
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BioDelivery Sciences International
INDUSTRY
Responsible Party
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Principal Investigators
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M. Todd Kirby, PhD
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Horizon Research Group, Inc./Alabama Orthopedic Clinic
Mobile, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Global Research
Anaheim, California, United States
Catalina Research Institute, LLC
Chino, California, United States
Synergy Clinical Research Center of Escondido
Escondido, California, United States
Adam D. Karns MD
Los Angeles, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Clinical Research of West Florida - Clearwater
Clearwater, Florida, United States
Century Clinical Research, Inc.
Daytona Beach, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Florida Health Center
Fort Lauderdale, Florida, United States
Eastern Research, Inc.
Hialeah, Florida, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Drug Study Institute
Jupiter, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
NEMA Research, Inc.
Naples, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Peninsula Research
Ormond Beach, Florida, United States
Gold Coast Research, L.L.C.
Plantation, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Clinical Research of West Florida - Tampa
Tampa, Florida, United States
National Pain Research Institute, LLC
Winter Park, Florida, United States
Atlanta Research Center
Atlanta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Taylor Research, LLC
Marietta, Georgia, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
International Clinical Research Institute, Inc.
Overland Park, Kansas, United States
Willis-Kinghton Physician Network/River Interventional Pain Specialist
Bossier City, Louisiana, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
Best Clinical Trials, Inc.
New Orleans, Louisiana, United States
River Cities Clinical Research Center
Shreveport, Louisiana, United States
MedVadis Research Corp.
Watertown, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
The Center for Clinical Trials
Biloxi, Mississippi, United States
Office of Robert Kaplan, DO
Las Vegas, Nevada, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
Upstate Clinical Research Associates LLC
Williamsville, New York, United States
PharmQuest, LLC
Greensboro, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, United States
Clinical Inquest Center, Ltd.
Beavercreek, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Optimed Research, Ltd.
Columbus, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
NPC Research
Oklahoma City, Oklahoma, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
FutureSearch Clinical Trials - Austin
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Advanced Clinical Research of Houston
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Clinical Investigations Specialists, Inc.
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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EN3409-308
Identifier Type: -
Identifier Source: org_study_id
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