A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: Meloxicam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Ltd./Bracknell

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

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

Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Boehringer Ingelheim Investigational Site, Buenos Aires 1427, Argentina

Boehringer Ingelheim Investigational Site, Buenos Aires 1405, Argentina

Boehringer Ingelheim Investigational Site, Rosario 2000, Argentina

Boehringer Ingelheim Investigational Site, Buenos Aires 1428, Argentina

Clinique du Parc Léopold, Bruxelles 1040, Belgium

Medisch Centrum van Huisartsen, Leuven 3000, Belgium

Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia, São Paulo - SP 04230-000, Brazil

Av Anhanguera 6479, Goiânia GO 74043-011, Brazil

Rua Ramiro Barcelos 2350, Porto Alegre RS 90035-003, Brazil

Boehringer Ingelheim Investigational Site, São Paulo - SP 04040-000, Brazil

Boehringer Ingelheim Investigational Site, Tours 37000, France

Boehringer Ingelheim Investigational Site, Nice 06000, France

Boehringer Ingelheim Investigational Site, Marseille 13008, France

Boehringer Ingelheim Investigational Site, Tours cedex 9 37044, France

Rheumatologie und Physikalische Therapie, Berlin 14059, Germany

Boehringer Ingelheim Investigational Site, München 81541, Germany

Boehringer Ingelheim Investigational Site, Aachen 52064, Germany

Boehringer Ingelheim Investigational Site, Bad Segeberg 23795, Germany

Boehringer Ingelheim Investigational Site, Steinhöring 85643, Germany

Boehringer Ingelheim Investigational Site, Klotten 56818, Germany

Boehringer Ingelheim Investigational Site, Nürnberg 90402, Germany

Elisabeth-Krankenhaus, Essen 45356, Germany

Boehringer Ingelheim Investigational Site, Nürnberg 90461, Germany

Augusta-Klinik, Bad Kreuznach 55543, Germany

Boehringer Ingelheim Investigational Site, Ellefeld 08236, Germany

Klinik für Rheumatologie,, Wiesbaden 65191, Germany

ClinPharm International GmbH & Co. KG, Leipzig 04229, Germany

Boehringer Ingelheim Investigational Site, Tübingen 72070, Germany

Hungarian Brothers of St. John of Good, Pecs 7621, Hungary

Pál Almási Balogh Hospital, Ózd 3601, Hungary

Ferenc Csolnoky County Hospital, Veszprem 8201, Hungary

Aladár Petz County Hospital, Györ 9024, Hungary

Szegedi University, Szeged 6720, Hungary

DOTE, Debrecen 4031, Hungary

St. Andrew State Hospital, Hévíz 8380, Hungary

St. Ferenc Hospital, Miskolc 3501, Hungary

National Institute for Rheumatology and Physiotherapy, Budapest 1027, Hungary

Università degli Studi, Genova, Italy

Ospedale Augusto Murri, JESI 60035, Italy

Ospedale A. Galateo, SAN CESARIO (Lecce) 73016, Italy

Università degli Studi di Napoli "Federico II", NAPOLI 80131, Italy

Boehringer Ingelheim Investigational Site, Seoul 120-752, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

San-5, Woncheon-Dong, Paldal-Gu, Gyeonggi-Do 442-721, Korea, Republic of

896 Pyung Chon-Dong, Dongan-Gu, Gyeonggi-Do 431-070, Korea, Republic of

85 Jeo-Dong 2Ga, Seoul 100-032, Korea, Republic of

Institute of Rheumatology of RAMN, Moscow 115522, Russian Federation

City Clinical Hospital No. 1, Moscow 117049, Russian Federation

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan

Taipei Veterans General Hospital, Taipei, Taiwan

Chang Gung Memorial Hospital, Taipei 105, Taiwan

Rheumatology-Allergy-Immunology, Kaohsiung, Taiwan

Institute of Cardiology, Kiev 03151, Ukraine

Institute of Gerontology, Kyiv 04114, Ukraine

Central Clinical Hospital, Kiev 01023, Ukraine

Regional Hospital No. 1, Kiev 04107, Ukraine

State Medical University, Donetsk 83114, Ukraine

Central City Hospital, Donetsk 83098, Ukraine

Municipal Institute of Health Care, Kharkov 61091, Ukraine

City Multitype Clinical Hospital No. 25, Kharkov 61115, Ukraine

Dnyepropyetrovsk Medical Academy, Dnyepropetrovsk 49044, Ukraine

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#106, Glendale, Arizona 85308, United States

Boehringer Ingelheim Investigational Site, Victoria, British Columbia V8P 5P6, Canada

230-6091, Richmond, British Columbia V7C 5L9, Canada

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Suite 406, Safety Harbor, Florida 34695, United States

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Boehringer Ingelheim Investigational Site, Gainsville, Florida 32607, United States

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Boehringer Ingelheim Investigational Site, Coeur d'Alene, Idaho 83814-2644, United States

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Boehringer Ingelheim Investigational Site, Indianapolis, Indiana 46202, United States

Attn: Kathy Stoddard, Director, Wichita, Kansas 67207, United States

Suite 306, Wheaton, Maryland 20902, United States

Truesdale Clinic, Fall River, Massachusetts 02720, United States

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Suite 240, St. Louis, Missouri 63141, United States

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Boehringer Ingelheim Investigational Site, Lincoln, Nebraska 68506, United States

Boehringer Ingelheim Investigational Site, Reno, Nevada 89502-1196, United States

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PC, Jackson Commons D-2, Medford, New Jersey 08055, United States

Boehringer Ingelheim Investigational Site, New York, New York 10021, United States

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Dr. Denis O'Donnell, Kingston, Ontario K7L 2V6, Canada

Boehringer Ingelheim Investigational Site, Sarnia, Ontario N7T 4X3, Canada

Boehringer Ingelheim Investigational Site, Toronto, Ontario M3B 2H9, Canada

Boehringer Ingelheim Investigational Site, Ottawa, Ontario K2P 1V3, Canada

Boehringer Ingelheim Investigational Site, Peterborough, Ontario K9J 7H8, Canada

104-532, St. Catharines, Ontario L2N 4H4, Canada

Trillium Health Centre, Mississauga, Ontario L5B 4A2, Canada

Boehringer Ingelheim Investigational Site, Corunna, Ontario N0N 1G0, Canada

Boehringer Ingelheim Investigational Site, Windsor, Ontario N8W 5L7, Canada

Boehringer Ingelheim Investigational Site, Hamilton, Ontario L8N 1Y2, Canada

Boehringer Ingelheim Investigational Site, Scarborough, Ontario M1B 4Y9, Canada

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Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

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Boehringer Ingelheim Investigational Site, Pointe-Claire, Quebec H9R 3J1, Canada

Boehringer Ingelheim Investigational Site, Cotton Tree, Queensland 4558, Australia

Suite 331-333, Johnston, Rhode Island 02919, United States

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Boehringer Ingelheim Investigational Site, Orangeburg, South Carolina 29118, United States

Boehringer Ingelheim Investigational Site, Columbia, South Carolina 29204, United States

Boehringer Ingelheim Investigational Site, Austin, Texas 78705, United States

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Suite 500, Lubbock, Texas 79410, United States

Emeritus Research, MALVERN, Victoria 3144, Australia

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Boehringer Ingelheim Investigational Site, Everett, Washington 98201, United States

Boehringer Ingelheim Investigational Site, Yakima, Washington 98902, United States

Department of Rheumatology, Perth, Western Australia 6004, Australia

Starting date: June 2002
Ending date: July 2003
Last updated: April 3, 2008