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Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy Clinical research trials and Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy. Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy clinical trial. Human subjects often obtain the finest healthcare possible for their Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy  Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
For Condition: Diabetic Neuropathy, Painful
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. It is a selective antagonist that binds competitively to the glutamate site of the N-methyl-Daspartate (NMDA) receptor. This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with placebo in subjects with neuropathic pain associated with diabetic neuropathy.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Outpatients. - At least 18 years of age. - Women of childbearing potential must have a negative serum pregnancy test result at screening. The signed informed consent should reflect an awareness of the stipulations concerning the use of contraception. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose partners are either sterile or using contraceptives. Sexually active women participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used double-barrier methods. - Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet. Glycosylated hemoglobin (HbA1C) 9% at screen. A subject with HbA1C > 9% but <11% may be given a maximum of 3 months to optimize his/her glucose control under the supervision of an endocrinologist. If the endocrinologist feels that no further improvement is possible at the end of the optimization period, the subject may be enrolled, providing that HbA1C remains < 11%. This effort will be discussed with and approved by the medical monitor and documented in the source documents. Specific screening assessments will be repeated at the end of the period to confirm that entry criteria are still met. - Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy. The primary site of symptoms must be the lower extremity. Signs and symptoms of diabetic polyneuropathy must be confirmed by a neurologist or endocrinologist. Symptoms referable to painful diabetic neuropathy present for at least 3 months before screening. - Average total daytime and nighttime pain score 4 on the numeric rating scale during the screening period. At least 12 observations (ie, 6 days worth of daytime and nighttime recordings) must be recorded within the 10 days before randomization. - At least 1 abnormality of nerve conduction studies (NCS) or vibratory perception threshold (VPT) as determined by the normative data at the core laboratory. - Subjects on a stable analgesic regimen for other indications may be enrolled, provided that the investigator does not consider these medications to be effective against neuropathic pain. This does not include anticonvulsants, tricyclic antidepressants, selective serotonin-norepinephrine reuptake inhibitors, or tramadol, which are prohibited during the study. Opioids are also prohibited during the study, except for up to 30 mg of codeine with acetaminophen, which is permitted as rescue medication. - Stable chest x-ray report within 2 years before the baseline visit. If not available, a chest x-ray must be performed before randomization. - Signed and dated informed consent before any study related procedures are performed. Exclusion Criteria: - Pregnancy, lactation, or plans to become pregnant during the study. - Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control. - History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator. - Unstable diabetic control (refer to Inclusion Criterion 4 for definition of adequate diabetic control). - Treatment within 14 days before the first dose of test article (study day 1) with agents effective against the subject’s neuropathic pain, such as anticonvulsants, tricyclic antidepressants, selective serotonin-norepinephrine reuptake inhibitors, opiates, or tramadol. If the subject is currently taking any of these drugs and deems them to be ineffective against his/her neuropathic pain, the medication must be discontinued over a 14-day washout before receiving test article. Exceptions are those medications specifically permitted for rescue medication. - Failure due to lack of efficacy (not for inability to tolerate the medication) at maximum therapeutic doses and over appropriate durations in 2 or more previous treatment regimens with agents felt to be effective for neuropathic pain. - Use of prohibited treatments. Refer to sections 16.2 (Permitted Treatment) and 16.3 (Prohibited Treatment) and the Excluded Treatments chart for treatments and associated timeframes. - Other neurologic disorder that, in the opinion of the investigator, confounds the assessment of painful diabetic symmetric sensory/motor polyneuropathy, such as pure small fiber neuropathy, lumbosacral radiculopathy, proximal diabetic lumbosacral radiculopathy, and mononeuritis multiplex. - Presence of any central or peripheral nervous system condition(s) that might mimic polyneuropathy. - Presence of significant asymmetrical neuropathic signs and symptoms. - Presence of a neuropathy that is not due to diabetes in the judgment of the investigator. This may include significant vasculitis, collagen vascular disorder, medications known to cause neuropathies, history of familial neuropathy, drug and/or alcohol abuse, hepatitis or human immunodeficiency virus (HIV) infection, and pernicious anemia. - Other forms of pain that may confuse the self-evaluation of diabetic neuropathic pain. - History of seizure disorder other than a single childhood febrile seizure. - History of any malignancy other than basal cell carcinomas of the skin. - History or presence of any unstable hepatic, renal, pulmonary, cardiovascular, or psychiatric disease; peripheral vascular disease as evidenced by symptomatic ischemic claudication, or any other medical condition that might compromise the study or put the subject at greater risk during study participation. - History of significant depression before the onset of neuropathic pain symptoms. - Score of 2 or 3 on item 9 of the Beck Depression Inventory II (BDI-II) or other evidence that the subject may be at significant risk of self-harm in the opinion of the investigator. - Current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs. - Clinically important abnormalities, as determined by the investigator, on screening physical examination,electrocardiogram (ECG), ophthalmologic examination,laboratory tests, urine drug screen (UDS), or chest x-ray. - Presence or history of ischemic foot ulcer or amputation for vascular disease. - Severe retinopathy based on ophthalmic examination. - Creatinine clearance 50 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation). Note: Proteinuria is not exclusionary. - Liver function tests (LFTs) > 3 times upper normal limit. - WBCs < 2500 mm3; platelets < 75,000 mm3; or neutrophils < 1500 mm3. - Acute illness within 1 week of screening.
Total Enrollment:
Location and Contact Information:
University of Oklahoma *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting LeAnn Olansky 405-271-8854
The Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Angelo Licata 216-444-6248
Research Site *Recruiting*
Chicago, Illinois, 60610
United States
Recruiting Robert Harden 312-238-7878
The Center for Diabetes and Endocrine Care *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Sam Lerman 954-963-7100
St. Louis Center for Clinical Research *Recruiting*
St. Louis, Missouri, 63128
United States
Recruiting Rudee Suwannasri 314-543-5225
Center for Pharmaceutical Research *Recruiting*
Kansas City, Missouri, 64114
United States
Recruiting John Ervin 816-943-0770
Diabetes Care and Information Center *Recruiting*
Flushing, New York, 11365
United States
Recruiting Daniel Lorber 718-661-2536
Dallas Diabetes and Endocrine Center *Recruiting*
Dallas, Texas, 75230-2513
United States
Recruiting Julio Rosenstock 214-661-7020
Diabetes & Glandular Disease Research Associates, P.A. *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Sherwyn Schwartz 210-615-5564
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Pricilla Hollander 214-820-3466
Colorado Neurology and Headache Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Jack Klapper 303-839-9900
Research Solutions, LLC *Recruiting*
Evansville, Indiana, 47714
United States
Recruiting Jennifer Wahle 812-473-0141
Radiant Research-Cincinnati *Recruiting*
Cincinnati, Ohio, 45236
United States
Recruiting Michael Noss 513-984-6887
Palm Beach Neurological Center *Recruiting*
Palm Beach Gardens, Florida, 33410
United States
Recruiting Michael Tuchman 561-694-1010
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Janet McGill 314-362-8681
Peripheral Neurophathy Center *Recruiting*
New York City, New York, 10022
United States
Recruiting Thomas Brannagan 212-888-8516
Yale University *Recruiting*
New Haven, Connecticut, 06510
United States
Recruiting Steven Novella 203-785-6141
Lehigh Valley Hospital Neurosciences & Pain Research *Recruiting*
Allentown, Pennsylvania, 18103
United States
Recruiting Bruce Nicholson 610-402-9008
Alpine Clinical Research Center *Recruiting*
Boulder, Colorado, 80304
United States
Recruiting Paul Brownstone 303-443-7229
The Medical Research Network, L.L.C. *Recruiting*
New York City, New York, 10024
United States
Recruiting Mohsin Ali 212-595-5012
Diablo Clinical Research *Recruiting*
Walnut Creek, California, 94598-3300
United States
Recruiting Richard Weinstein 925-930-7267
CNS Research, Inc. *Recruiting*
Providence, Rhode Island, 02916
United States
Recruiting Norman Gordon 800-707-6013
Metrolina Medical Research *Recruiting*
Charlotte, North Carolina, 28209
United States
Recruiting Hemanth Rao 704-527-6672
New Britain General Hospital *Recruiting*
New Britain, Connecticut, 06050
United States
Recruiting William Petit 860-224-5900
Pivotal Research Centers *Recruiting*
Peoria, Illinois, 85381
United States
Recruiting Louis III 623-815-9714
Metabolic Research Institute, Inc. *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Barry Horowitz 561-802-3060
Broward Research Group *Recruiting*
Pembroke Pines, Florida, 33026
United States
Recruiting David Seiden 954-322-1600
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Roy Freeman 617-632-8454
Axiom Clinical Research of Florida *Recruiting*
Tampa, Florida, 33609
United States
Recruiting Stephen Sergay 813-353-9613
Baystate Medical Associates *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting Burritt Haag 413-794-7031
Neurology Center of Ohio *Recruiting*
Toledo, Ohio, 43623
United States
Recruiting Gary Gerard 419-885-8848
Additional Information:
Study ID Numbers: 0912A2-212-NA;
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073034
Other Diabetic Neuropathy, Painful Studies:
1. Investigational compound versus Placebo in the Treatment of Painful Diabetic Neuropathy
2. Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
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Study Of 3 Fixed Doses Of EAA-090 In Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
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