Long-term Open-Label Safety Study to Evaluate EN3409



Status:Completed
Conditions:Arthritis, Back Pain, Osteoarthritis (OA), Neurology
Therapuetic Areas:Musculoskeletal, Neurology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/20/2018
Start Date:December 2012
End Date:November 2014

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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

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.


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
We found this trial at
57
sites
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Clearwater, FL
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400 Tower Rd Ne
Marietta, Georgia 30060
678-581-5252
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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5430 Fredericksburg Road
San Antonio, Texas 78229
210-377-2873
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Anaheim, California 92804
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Austin, Texas 78756
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Bay City, Michigan 48706
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Beavercreek, Ohio 45432
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Biloxi, Mississippi 39531
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Birmingham, Alabama 35215
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Blue Ridge, Georgia 30513
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Bossier City, Louisiana 71111
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Cadillac, Michigan 49601
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Charleston, South Carolina 29406
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Cincinnati, Ohio 45242
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Dallas, Texas 75231
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Dallas, Texas 75230
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Daytona Beach, Florida 32117
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Downingtown, Pennsylvania 19335
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Duncansville, Pennsylvania 16635
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Escondido, California 92025
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Evansville, Indiana 47714
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Fall River, Massachusetts 02720
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Fargo, North Dakota 58104
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Fort Lauderdale, Florida 33312
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Franklin, Ohio 45005
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Garden Grove, California 92843
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Great Neck, New York 11023
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Hialeah, Florida 33013
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Jacksonville, Florida 32216
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Jupiter, Florida 33458
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Kenosha, Wisconsin 53142
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Long Beach, California 90807
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Los Angeles, California 90036
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Marietta, Georgia 30060
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Metairie, Louisiana 70006
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Mobile, Alabama 36608
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New Orleans, Louisiana 70115
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Norcross, Georgia 30092
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Oakland Park, Florida 33334
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Phoenix, Arizona 85023
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Plantation, Florida 33317
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Port Orange, Florida 32127
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Rapid City, South Dakota 57702
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Salt Lake City, Utah 84124
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Shreveport, Louisiana 71105
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Stamford, Connecticut 06095
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5115 North Armenia Avenue
Tampa, Florida 33603
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Tiffin, Ohio 44883
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West Des Moines, Iowa 50265
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Williamsville, New York 14221
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Winston-Salem, North Carolina 27103
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Winter Park, Florida 32789
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