A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
NCT ID: NCT00042068
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2002-06-30
2003-07-31
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
DOUBLE
Interventions
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Meloxicam
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim Ltd./Bracknell
Locations
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Suites 570 (research) & 600 (PI)
Huntsville, Alabama, United States
Suite 200
Montgomery, Alabama, United States
Suite 140
Anchorage, Alaska, United States
#106
Glendale, Arizona, United States
Suite 601
Phoenix, Arizona, United States
Suite 201
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Pasadena, California, United States
Suite 100
Rancho Cucamonga, California, United States
Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
Suite 208
San Diego, California, United States
Suite 202
San Diego, California, United States
Suite 301
San Leandro, California, United States
Suite A
Santa Maria, California, United States
Westlake Medical Research
Westlake Village, California, United States
Suite 200
Colorado Springs, Colorado, United States
Suites 205 & 206
Danbury, Connecticut, United States
Suite 300
Washington D.C., District of Columbia, United States
Boehringer Ingelheim Investigational Site
Delray Beach, Florida, United States
Boehringer Ingelheim Investigational Site
Gainsville, Florida, United States
Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
Boehringer Ingelheim Investigational Site
Largo, Florida, United States
Suite 202
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Suite 2
Orlando, Florida, United States
Suite 406
Safety Harbor, Florida, United States
Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States
Boehringer Ingelheim Investigational Site
South Miami, Florida, United States
Suite 101
St. Petersburg, Florida, United States
Radiant Research
Stuart, Florida, United States
Suite 203
Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
Zephyrhills, Florida, United States
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
Suite 202
Idaho Falls, Idaho, United States
Boehringer Ingelheim Investigational Site
Lake Forest, Illinois, United States
Boehringer Ingelheim Investigational Site
Rockford, Illinois, United States
Boehringer Ingelheim Investigational Site
Springfield, Illinois, United States
Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
Attn: Kathy Stoddard, Director
Wichita, Kansas, United States
Suite 306
Wheaton, Maryland, United States
Truesdale Clinic
Fall River, Massachusetts, United States
Suite 202
Kalamazoo, Michigan, United States
Suite 101
St Louis, Missouri, United States
Suite 240
St Louis, Missouri, United States
Boehringer Ingelheim Investigational Site
Lincoln, Nebraska, United States
Boehringer Ingelheim Investigational Site
Reno, Nevada, United States
PC, Jackson Commons D-2
Medford, New Jersey, United States
Suite 8
Mercerville, New Jersey, United States
Boehringer Ingelheim Investigational Site
New York, New York, United States
Suite 100
Charlotte, North Carolina, United States
Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
Boehringer Ingelheim Investigational Site
Camp Hill, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Boehringer Ingelheim Investigational Site
Erie, Pennsylvania, United States
Suite D
Mechanicsburg, Pennsylvania, United States
Suite 331-333
Johnston, Rhode Island, United States
Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
Suite H
North Charleston, South Carolina, United States
Boehringer Ingelheim Investigational Site
Orangeburg, South Carolina, United States
Boehringer Ingelheim Investigational Site
Austin, Texas, United States
Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
Radiant Research
Dallas, Texas, United States
Suite 200
Dallas, Texas, United States
Suite 500
Lubbock, Texas, United States
Suites 207
San Antonio, Texas, United States
Suite 2A
Falls Church, Virginia, United States
Boehringer Ingelheim Investigational Site
Everett, Washington, United States
Suite D-3
Seattle, Washington, United States
Boehringer Ingelheim Investigational Site
Yakima, Washington, United States
Boehringer Ingelheim Investigational Site
Buenos Aires, , Argentina
Boehringer Ingelheim Investigational Site
Buenos Aires, , Argentina
Boehringer Ingelheim Investigational Site
Buenos Aires, , Argentina
Boehringer Ingelheim Investigational Site
Rosario, , Argentina
Boehringer Ingelheim Investigational Site
Cotton Tree, Queensland, Australia
Emeritus Research
Malvern, Victoria, Australia
Department of Rheumatology
Perth, Western Australia, Australia
Clinique du Parc Léopold
Brussels, , Belgium
Medisch Centrum van Huisartsen
Leuven, , Belgium
Av Anhanguera 6479
Goiânia GO, , Brazil
Rua Ramiro Barcelos 2350
Porto Alegre RS, , Brazil
Boehringer Ingelheim Investigational Site
São Paulo - SP, , Brazil
Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
São Paulo - SP, , Brazil
230-6091
Richmond, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Corunna, Ontario, Canada
Boehringer Ingelheim Investigational Site
Fort Erie, Ontario, Canada
Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
Dr. Denis O'Donnell
Kingston, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Boehringer Ingelheim Investigational Site
Peterborough, Ontario, Canada
Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
Boehringer Ingelheim Investigational Site
Scarborough Village, Ontario, Canada
104-532
St. Catharines, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Boehringer Ingelheim Investigational Site
Windsor, Ontario, Canada
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Boehringer Ingelheim Investigational Site
Pointe-Claire, Quebec, Canada
Boehringer Ingelheim Investigational Site
Marseille, , France
Boehringer Ingelheim Investigational Site
Nice, , France
Boehringer Ingelheim Investigational Site
Tours, , France
Boehringer Ingelheim Investigational Site
Tours, , France
Boehringer Ingelheim Investigational Site
Aachen, , Germany
Augusta-Klinik
Bad Kreuznach, , Germany
Boehringer Ingelheim Investigational Site
Bad Segeberg, , Germany
Rheumatologie und Physikalische Therapie
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Ellefeld, , Germany
Elisabeth-Krankenhaus
Essen, , Germany
Boehringer Ingelheim Investigational Site
Klotten, , Germany
ClinPharm International GmbH & Co. KG
Leipzig, , Germany
Boehringer Ingelheim Investigational Site
München, , Germany
Boehringer Ingelheim Investigational Site
Nuremberg, , Germany
Boehringer Ingelheim Investigational Site
Nuremberg, , Germany
Boehringer Ingelheim Investigational Site
Steinhöring, , Germany
Boehringer Ingelheim Investigational Site
Tübingen, , Germany
Klinik für Rheumatologie,
Wiesbaden, , Germany
National Institute for Rheumatology and Physiotherapy
Budapest, , Hungary
DOTE
Debrecen, , Hungary
Aladár Petz County Hospital
Győr, , Hungary
St. Andrew State Hospital
Hévíz, , Hungary
St. Ferenc Hospital
Miskolc, , Hungary
Pál Almási Balogh Hospital
Ózd, , Hungary
Hungarian Brothers of St. John of Good
Pécs, , Hungary
Szegedi University
Szeged, , Hungary
Ferenc Csolnoky County Hospital
Veszprém, , Hungary
Università degli Studi
Genova, , Italy
Ospedale Augusto Murri
Iesi, , Italy
Università degli Studi di Napoli "Federico II"
Napoli, , Italy
Ospedale A. Galateo
SAN Cesario (Lecce), , Italy
Institute of Rheumatology of RAMN
Moscow, , Russia
City Clinical Hospital No. 1
Moscow, , Russia
896 Pyung Chon-Dong, Dongan-Gu
Gyeonggi-do, , South Korea
San-5, Woncheon-Dong, Paldal-Gu
Gyeonggi-do, , South Korea
85 Jeo-Dong 2Ga
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Boehringer Ingelheim Investigational Site
Seoul, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Rheumatology-Allergy-Immunology
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Dnyepropyetrovsk Medical Academy
Dnyepropetrovsk, , Ukraine
Central City Hospital
Donetsk, , Ukraine
State Medical University
Donetsk, , Ukraine
Municipal Institute of Health Care
Kharkiv, , Ukraine
City Multitype Clinical Hospital No. 25
Kharkiv, , Ukraine
Central Clinical Hospital
Kiev, , Ukraine
Institute of Cardiology
Kiev, , Ukraine
Regional Hospital No. 1
Kiev, , Ukraine
Institute of Gerontology
Kyiv, , Ukraine
Countries
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Other Identifiers
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107.258
Identifier Type: -
Identifier Source: org_study_id