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A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. Clinical research trials and A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis.. A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. clinical trial. Test subjects typically receive the most expert healthcare available for their A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis. A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis.
A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis.
For Condition: Rheumatoid Arthritis
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
Details: The primary aim of this trial is to compare the efficacy and safety of several doses of meloxicam (7.5 mg, 15 mg, and 22.5 mg) administered once daily with placebo over a period of 12 weeks in treatment of patients with RA. There will be 700 US patients enrolled and 500 US patients entered in 65-70 US sites.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Age greater than or equal to 18 and less than or equal to 80. - Diagnosis of Rheumatoid Arthritis for at least six weeks. - Taking an NSAID. - If female: using adequate contraception. - Willingness to stop current NSAID until criteria reached to begin study drug. - Able to provide written informed consent. EXCLUSION CRITERIA: - Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug. - Pregnancy, lactating. - Use of investigational drug within 30 days prior to entering the trial. - History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding. - History of cerebrovascular or other bleeding disorder. - Severe hypertension. - Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator’s opinion). - RA of functional class IV. - Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial. - Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day). - DMARDs initiated within past three months or dose changed less than two months before entering the trial. - Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial. - Concomitant therapy with ACTH within past month before entering the trial. - History of narcotic or alcohol abuse (past 12 months). - Abnormal laboratory values. - Previous participation in the present trial.
Total Enrollment:
Location and Contact Information:
Westlake Medical Research, Inc.
Westlake Village, California, 91361
United States
Scott Toder, MD
Johnston, Rhode Island, 02919
United States
SW Florida Clinical Research Center
Tampa, Florida, 33609
United States
Arthritis Associates Inc.
Orlando, Florida, 32804
United States
Advanced Clinical Therapeutics, LLC (ACT)
Anchorage, Alaska, 99508
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
NTouch Research
St. Petersburg, Florida, 33710
United States
Florida Medical Research Institute PA
Gainesville, Florida, 32607
United States
Healthcard Research Consultants
Tulsa, Oklahoma, 74135
United States
Radiant Research
Stuart, Florida, 34996
United States
The Arthritis Center
Springfield, Illinois, 62704
United States
Radiant Research Dallas
Dallas, Texas, 75235
United States
Arthritis Northwest
Seattle, Washington, 98166
United States
Arthritis Center of Texas
Dallas, Texas, 75246-1632
United States
Phase III Clinical Research
Fall River, Massachusetts, 02720
United States
Florida Medical Clinic, PA Clinical Research Division
Zephyrhills, Florida, 33540
United States
DMI Health Care
Largo, Florida, 33773
United States
NCCR
Chicago, Illinois, 60611
United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
United States
The Arthritis and Osteoporosis Center
Orangeburg, North Carolina, 29118
United States
San Antonio Center for Clinical Research
San Antonio, Texas, 78217
United States
Sarasota Arthritis Center
Sarasota, Florida, 34239
United States
St. Louis Center for Clinical Research
St. Louis, Missouri, 63141
United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454
United States
Alan Brodsky, M.D.
Dallas, Texas, 75225
United States
Arthritis Regional Research Center
Mercerville, New Jersey, 08619
United States
Clinical Trials, N.W.
Yakima, Washington, 98902
United States
Sun Valley Arthritis Center, Ltd.
Glendale, Arizona, 85308
United States
Metropolitan Clinical Research
Falls Church, Virginia, 22044
United States
Low Country Research
North Charleston, South Carolina, 29406
United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730
United States
Rheumatology, PC
Kalamazoo, Michigan, 49009
United States
Indiana University Medical Center, Dept. of Medicine
Indianapolis, Indiana, 46202
United States
East Bay Rheumatology Medical Group
San Leandro, California, 94578
United States
Arthritis Associates Clinical Research of So. Florida
Delray Beach, Florida, 33484
United States
Walter F. Chase, M.D. PA
Austin, Texas, 78705
United States
The Wallace Rheumatic Study Center
Los Angeles, California, 90048
United States
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, 80910
United States
Irene Tong, M.D.
Pasadena, California, 91105
United States
Rheumatology Assoc. of North Alabama
Huntsville, Alabama, 35801
United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
United States
Clinical Research Center of CT/NY
Danbury, Connecticut, 06810
United States
Arthritis and Rehab Center of Jacksonville, Inc.
Jacksonville, Florida, 32204
United States
Columbia Arthritis Center
Columbia, South Carolina, 29204
United States
Advances in Medicine
Rancho Mirage, California, 92270
United States
Arthritis and Osteoporosis Assoc.
Lubbock, Texas, 79410
United States
North Shore Rheumatology
Lake Forest, Illinois, 60045
United States
Rheumatology and Arthritis Associates
Medford, New Jersey, 08055
United States
Wendt Bristol Research Center
Columbus, Ohio, 43214
United States
Renstar Medical Research
Ocala, Florida, 34471
United States
The Center for Arthritis and Rheumatic Disease
Miami, Florida, 33143
United States
Arthritis Center of Nebraska
Lincoln, Nebraska, 68506
United States
Internal Medicine
Camp Hill, Pennsylvania, 17011
United States
The Center for Rheumatology and Bone Research
Washington D.C., District of Columbia, 20006
United States
Clinical Research of Tampa Bay
Safety Harbor, Florida, 34695
United States
Arthritis Consultants, Inc.
St. Louis, Missouri, 63141
United States
Phoenix Center for Clinical Research
Phoenix, Arizona, 85015
United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120
United States
Tampa Medical Group Research
Tampa, Florida, 33614
United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207
United States
Miami Research Associates
Miami, Florida, 33173
United States
Coeur d'Alene Arthritis Clinical Trials
Coeur D Alene, Idaho, 83814
United States
Miami Research Associates
Miami, Florida, 33173
United States
Physician's Pharmaceutical Study Services
Everett, Washington, 98201
United States
Rockford Clinic
Rockford, Illinois, 60045
United States
Stephen Bookbinder, M.D.
Ocala, Florida, 03474
United States
Hospital for Special Surgery
New York City, New York, 10021
United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055
United States
C.a.R.E
Erie, Pennsylvania, 16508
United States
Arthritis Center of Reno
Reno, Nevada, 89502
United States
Radiant Research
San Diego, California, 92108
United States
Additional Information:
Study ID Numbers: BI 107.258;
Study Start Date: July 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042068
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A multi-center trial to compare the efficacy and safety of three doses of Meloxicam and placebo in patients with Rheumatoid Arthritis.
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