Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT00603265
Last Updated: 2015-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2007-11-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ADL5859
2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
ADL5859
Duloxetine
2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
Duloxetine
Placebo
Placebo
2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Placebo
Interventions
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ADL5859
Duloxetine
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight of at least 45 kilograms (kg)
* Diabetes mellitus (type I or II) that is documented to be under stable glycemic control over a period of at least 3 months, as indicated by a glycosylated hemoglobin (HbgAIC) of less than or equal to 12% and a stable dose of insulin or oral diabetic medication for 90 days prior to starting study medication
* No change in diabetic medications is planned for the duration of the study
* Evidence of symmetrical, bilateral pain in the lower extremities due to diabetic peripheral neuropathy (DPN)
* Presence of daily pain due to DPN for at least 3 months
* Score greater than or equal to 3 on the physical examination portion of the Michigan Neuropathy Screening Instrument (MNSI)
* Average weekly pain score of greater than or equal to 4 on the numeric pain rating scale (NPRS) for symmetrical neuropathic pain in the feet and legs
* For male participants, be surgically sterile or agree to use an appropriate method of contraception
* For female participants of childbearing potential, be surgically sterile or using an intrauterine device, or injectable, transdermal, or combination oral contraceptive deemed highly effective by the Food and Drug Administration (FDA)
* Be willing and able to comply with the protocol requirements
* Be able to understand and willing to provide written informed consent in English
Exclusion Criteria
* Presence of significant renal disease, as indicated by a serum creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL), or presence of significant hepatic disease
* Have a history of a seizure disorder
* Presence of serious or unstable cardiovascular disease, respiratory disease, hematologic illness, or a psychiatric condition
* History of evidence of symptomatic orthostatic hypotension
* History of a major depressive disorder, generalized anxiety disorder, eating disorder, or substance abuse (including alcohol) within the past year
* History or evidence of mania, bipolar disorder, or psychosis
* History of allergy to acetaminophen or duloxetine
* Score of greater than or equal to 18 on the Beck Depression Inventory II (BDI-II) or score of greater than zero on Item 9 of the BDI-II
* Use of any of the following concomitant medications: fluvoxamine; quinolone antimicrobials (ciprofloxacin and enoxacin); selective serotonin reuptake inhibitors (SSRIs); serotonin norepinephrine reuptake inhibitors (SNRIs); tricyclic antidepressants; opioids; nonsteroidal anti-inflammatory drugs (NSAIDS); anticonvulsants; aspirin (with the exception of low-dose aspirin as cardiovascular prophylaxis); or cytochrome P4503A (CYP3A) and P-glycoprotein transporter inhibitors
* Pregnant, lactating, or plans to become pregnant during the study
* Presence of foot or toe amputation
* Participation in another study with an investigational compound within the previous 30 days prior to study medication administration, or concurrent participation in another clinical study
18 Years
75 Years
ALL
No
Sponsors
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Berger, MD
Role: STUDY_DIRECTOR
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Locations
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Integrated Research Group
Riverside, California, United States
Torrance Clinical Research
Torrance, California, United States
FPA Clinical Research
Kissimmee, Florida, United States
Innovative Research of West Florida, Inc.
Largo, Florida, United States
Panhandle Family Care Associates & Emerald Coast Research Grp, Inc.
Marianna, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Radiant Research-St.Petersburg
Pinellas Park, Florida, United States
Doctor's Research Network
South Miami, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Laszlo J. Mate, MD
West Palm Beach, Florida, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States
Beacon Clinical Research
Brockton, Massachusetts, United States
Healthcare Research
Florissant, Missouri, United States
Creighton Diabetes Center, Creighton Univ. Sch. of Medicine
Omaha, Nebraska, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Clnical Study Center of Asheville
Asheville, North Carolina, United States
Radiant Research-Akron
Mogadore, Ohio, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States
Aquilo Research
Yukon, Oklahoma, United States
Clinical Research Consultants, Research Department
Medford, Oregon, United States
Advanced Regional Center for Clinical Research (Ankle & Foot Care)
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Nerve & Muscle Center of Texas
Houston, Texas, United States
Invisions Consultants LLC
San Antonio, Texas, United States
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, United States
S.A.M. Clinical Research Center
San Antonio, Texas, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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33CL231
Identifier Type: -
Identifier Source: org_study_id