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A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
This study has been completed.
First Received: July 22, 2002   Last Updated: September 24, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00042068
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Meloxicam
Phase III

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment: 1000
Study Start Date: June 2002
Estimated Study Completion Date: July 2003
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042068

  Hide Study Locations
Locations
United States, Alabama
Suites 570 (research) & 600 (PI)
Huntsville, Alabama, United States, 35801
Suite 200
Montgomery, Alabama, United States, 36106
United States, Alaska
Suite 140
Anchorage, Alaska, United States, 99508
United States, Arizona
Suite 601
Phoenix, Arizona, United States, 85012
Suite 201
Phoenix, Arizona, United States, 85015
#106
Glendale, Arizona, United States, 85308
United States, California
Westlake Medical Research
Westlake Village, California, United States, 91361
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States, 90048
Suite 100
Rancho Cucamonga, California, United States, 91730
Suite A
Santa Maria, California, United States, 93454
Suite 202
San Diego, California, United States, 92120
Boehringer Ingelheim Investigational Site
Pasadena, California, United States, 91105
Suite 208
San Diego, California, United States, 92108
Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States, 92270-4469
Suite 301
San Leandro, California, United States, 94578
United States, Colorado
Suite 200
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Suites 205 & 206
Danbury, Connecticut, United States, 06810
United States, District of Columbia
Suite 300
Washington, District of Columbia, United States, 20006
United States, Florida
Radiant Research
Stuart, Florida, United States, 34996
Renstar Medical Research
Ocala, Florida, United States, 34471
Suite 202
Miami, Florida, United States, 33173
Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States, 34239
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States, 32804
Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States, 32204
Boehringer Ingelheim Investigational Site
South Miami, Florida, United States, 33143
Suite 101
St. Petersburg, Florida, United States, 33710
Suite 406
Safety Harbor, Florida, United States, 34695
Boehringer Ingelheim Investigational Site
Largo, Florida, United States, 33773
Suite 2
Orlando, Florida, United States, 32806
Boehringer Ingelheim Investigational Site
Gainsville, Florida, United States, 32607
Suite 203
Tampa, Florida, United States, 33614
Boehringer Ingelheim Investigational Site
Zephyrhills, Florida, United States, 33540
Boehringer Ingelheim Investigational Site
Ocala, Florida, United States, 03474
Boehringer Ingelheim Investigational Site
Del Ray Beach, Florida, United States, 33484
United States, Idaho
Suite 202
Idaho Falls, Idaho, United States, 83404
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States, 83814-2644
United States, Illinois
Boehringer Ingelheim Investigational Site
Springfield, Illinois, United States, 62704
Boehringer Ingelheim Investigational Site
Lake Forest, Illinois, United States, 60045
Boehringer Ingelheim Investigational Site
Rockford, Illinois, United States, 61103
United States, Indiana
Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
Attn: Kathy Stoddard, Director
Wichita, Kansas, United States, 67207
United States, Maryland
Suite 306
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Truesdale Clinic
Fall River, Massachusetts, United States, 02720
United States, Michigan
Suite 202
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Suite 240
St. Louis, Missouri, United States, 63141
Suite 101
St. Louis, Missouri, United States, 63128
United States, Nebraska
Boehringer Ingelheim Investigational Site
Lincoln, Nebraska, United States, 68506
United States, Nevada
Boehringer Ingelheim Investigational Site
Reno, Nevada, United States, 89502-1196
United States, New Jersey
Suite 8
Mercerville, New Jersey, United States, 08619
PC, Jackson Commons D-2
Medford, New Jersey, United States, 08055
United States, New York
Boehringer Ingelheim Investigational Site
New York, New York, United States, 10021
United States, North Carolina
Suite 100
Charlotte, North Carolina, United States, 28210
United States, Ohio
Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States, 43214
United States, Oklahoma
Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Boehringer Ingelheim Investigational Site
Erie, Pennsylvania, United States, 16508-1256
Suite D
Mechanicsburg, Pennsylvania, United States, 17055
Boehringer Ingelheim Investigational Site
Camp Hill, Pennsylvania, United States, 17011
United States, Rhode Island
Suite 331-333
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Suite H
North Charleston, South Carolina, United States, 29406
Boehringer Ingelheim Investigational Site
Orangeburg, South Carolina, United States, 29118
Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States, 29204
United States, Texas
Boehringer Ingelheim Investigational Site
Dallas, Texas, United States, 75225
Suite 200
Dallas, Texas, United States, 75246-1632
Suites 207
San Antonio, Texas, United States, 78217
Radiant Research
Dallas, Texas, United States, 75231
Boehringer Ingelheim Investigational Site
Austin, Texas, United States, 78705
Suite 500
Lubbock, Texas, United States, 79410
United States, Virginia
Suite 2A
Falls Church, Virginia, United States, 22044
United States, Washington
Suite D-3
Seattle, Washington, United States, 98166-2967
Boehringer Ingelheim Investigational Site
Everett, Washington, United States, 98201
Boehringer Ingelheim Investigational Site
Yakima, Washington, United States, 98902
Argentina
Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina, 1428
Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina, 1405
Boehringer Ingelheim Investigational Site
Rosario, Argentina, 2000
Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina, 1427
Australia, Queensland
Boehringer Ingelheim Investigational Site
Cotton Tree, Queensland, Australia, 4558
Australia, Victoria
Emeritus Research
MALVERN, Victoria, Australia, 3144
Australia, Western Australia
Department of Rheumatology
Perth, Western Australia, Australia, 6004
Belgium
Clinique du Parc Léopold
Bruxelles, Belgium, 1040
Medisch Centrum van Huisartsen
Leuven, Belgium, 3000
Brazil
Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
São Paulo - SP, Brazil, 04230-000
Av Anhanguera 6479
Goiânia GO, Brazil, 74043-011
Rua Ramiro Barcelos 2350
Porto Alegre RS, Brazil, 90035-003
Boehringer Ingelheim Investigational Site
São Paulo - SP, Brazil, 04040-000
Canada, British Columbia
Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada, V8P 5P6
230-6091
Richmond, British Columbia, Canada, V7C 5L9
Canada, Ontario
Dr. Denis O'Donnell
Kingston, Ontario, Canada, K7L 2V6
Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada, M3B 2H9
Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada, K2P 1V3
Boehringer Ingelheim Investigational Site
Windsor, Ontario, Canada, N8W 5L7
104-532
St. Catharines, Ontario, Canada, L2N 4H4
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 4A2
Boehringer Ingelheim Investigational Site
Corunna, Ontario, Canada, N0N 1G0
Boehringer Ingelheim Investigational Site
Peterborough, Ontario, Canada, K9J 7H8
Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada, L8N 1Y2
Boehringer Ingelheim Investigational Site
Scarborough, Ontario, Canada, M1B 4Y9
Boehringer Ingelheim Investigational Site
Fort Erie, Ontario, Canada, L2A 1Z3
Canada, Quebec
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada, H3Z, 2Z3
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Boehringer Ingelheim Investigational Site
Pointe-Claire, Quebec, Canada, H9R 3J1
France
Boehringer Ingelheim Investigational Site
Tours, France, 37000
Boehringer Ingelheim Investigational Site
Nice, France, 06000
Boehringer Ingelheim Investigational Site
Marseille, France, 13008
Boehringer Ingelheim Investigational Site
Tours cedex 9, France, 37044
Germany
Boehringer Ingelheim Investigational Site
Nürnberg, Germany, 90461
Boehringer Ingelheim Investigational Site
München, Germany, 81541
Boehringer Ingelheim Investigational Site
Aachen, Germany, 52064
Boehringer Ingelheim Investigational Site
Bad Segeberg, Germany, 23795
Boehringer Ingelheim Investigational Site
Steinhöring, Germany, 85643
Boehringer Ingelheim Investigational Site
Klotten, Germany, 56818
Boehringer Ingelheim Investigational Site
Nürnberg, Germany, 90402
Elisabeth-Krankenhaus
Essen, Germany, 45356
Rheumatologie und Physikalische Therapie
Berlin, Germany, 14059
Augusta-Klinik
Bad Kreuznach, Germany, 55543
Boehringer Ingelheim Investigational Site
Ellefeld, Germany, 08236
Klinik für Rheumatologie,
Wiesbaden, Germany, 65191
ClinPharm International GmbH & Co. KG
Leipzig, Germany, 04229
Boehringer Ingelheim Investigational Site
Tübingen, Germany, 72070
Hungary
Szegedi University
Szeged, Hungary, 6720
Pál Almási Balogh Hospital
Ózd, Hungary, 3601
Ferenc Csolnoky County Hospital
Veszprem, Hungary, 8201
Aladár Petz County Hospital
Györ, Hungary, 9024
Hungarian Brothers of St. John of Good
Pecs, Hungary, 7621
DOTE
Debrecen, Hungary, 4031
St. Andrew State Hospital
Hévíz, Hungary, 8380
St. Ferenc Hospital
Miskolc, Hungary, 3501
National Institute for Rheumatology and Physiotherapy
Budapest, Hungary, 1027
Italy
Università degli Studi
Genova, Italy
Ospedale Augusto Murri
JESI, Italy, 60035
Ospedale A. Galateo
SAN CESARIO (Lecce), Italy, 73016
Università degli Studi di Napoli "Federico II"
NAPOLI, Italy, 80131
Korea, Republic of
Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of, 120-752
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
San-5, Woncheon-Dong, Paldal-Gu
Gyeonggi-Do, Korea, Republic of, 442-721
896 Pyung Chon-Dong, Dongan-Gu
Gyeonggi-Do, Korea, Republic of, 431-070
85 Jeo-Dong 2Ga
Seoul, Korea, Republic of, 100-032
Russian Federation
Institute of Rheumatology of RAMN
Moscow, Russian Federation, 115522
City Clinical Hospital No. 1
Moscow, Russian Federation, 117049
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Rheumatology-Allergy-Immunology
Kaohsiung, Taiwan
Ukraine
Dnyepropyetrovsk Medical Academy
Dnyepropetrovsk, Ukraine, 49044
Institute of Gerontology
Kyiv, Ukraine, 04114
Central Clinical Hospital
Kiev, Ukraine, 01023
Regional Hospital No. 1
Kiev, Ukraine, 04107
State Medical University
Donetsk, Ukraine, 83114
Central City Hospital
Donetsk, Ukraine, 83098
Municipal Institute of Health Care
Kharkov, Ukraine, 61091
City Multitype Clinical Hospital No. 25
Kharkov, Ukraine, 61115
Institute of Cardiology
Kiev, Ukraine, 03151
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
  More Information

Additional Information:
No publications provided

Study ID Numbers: 107.258
Study First Received: July 22, 2002
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00042068     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Meloxicam
Arthritis, Rheumatoid
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009