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

NCT00042068 | Completed Phase 3

• 1 other identifier: 107.258
• Study Type: interventional
• Target: 1,000
• Locations: 14 countries
• Sites: 153

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Response according to American College of Rheumatology 20% (ACR20) classification

  at 12 weeks

Secondary Outcomes (17)

• Number of painful or tender joints

  up to 12 weeks

• Number of swollen joints

  up to 12 weeks

• Patient's global (overall) assessment of disease activity

  up to 12 weeks

• Investigator's global (overall) assessment of disease activity

  up to 12 weeks

• Patient's assessment of pain

  up to 12 weeks

Interventions

Meloxicam DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (153)

Suites 570 (research) & 600 (PI)

Huntsville, Alabama, 35801, United States

Location

Suite 200

Montgomery, Alabama, 36106, United States

Location

Suite 140

Anchorage, Alaska, 99508, United States

Location

#106

Glendale, Arizona, 85308, United States

Location

Suite 601

Phoenix, Arizona, 85012, United States

Location

Suite 201

Phoenix, Arizona, 85015, United States

Location

Boehringer Ingelheim Investigational Site

Los Angeles, California, 90048, United States

Location

Boehringer Ingelheim Investigational Site

Pasadena, California, 91105, United States

Location

Suite 100

Rancho Cucamonga, California, 91730, United States

Location

Boehringer Ingelheim Investigational Site

Rancho Mirage, California, 92270-4469, United States

Location

Suite 208

San Diego, California, 92108, United States

Location

Suite 202

San Diego, California, 92120, United States

Location

Suite 301

San Leandro, California, 94578, United States

Location

Suite A

Santa Maria, California, 93454, United States

Location

Westlake Medical Research

Westlake Village, California, 91361, United States

Location

Suite 200

Colorado Springs, Colorado, 80910, United States

Location

Suites 205 & 206

Danbury, Connecticut, 06810, United States

Location

Suite 300

Washington D.C., District of Columbia, 20006, United States

Location

Boehringer Ingelheim Investigational Site

Delray Beach, Florida, 33484, United States

Location

Boehringer Ingelheim Investigational Site

Gainsville, Florida, 32607, United States

Location

Boehringer Ingelheim Investigational Site

Jacksonville, Florida, 32204, United States

Location

Boehringer Ingelheim Investigational Site

Largo, Florida, 33773, United States

Location

Suite 202

Miami, Florida, 33173, United States

Location

Boehringer Ingelheim Investigational Site

Ocala, Florida, 03474, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Boehringer Ingelheim Investigational Site

Orlando, Florida, 32804, United States

Location

Suite 2

Orlando, Florida, 32806, United States

Location

Suite 406

Safety Harbor, Florida, 34695, United States

Location

Boehringer Ingelheim Investigational Site

Sarasota, Florida, 34239, United States

Location

Boehringer Ingelheim Investigational Site

South Miami, Florida, 33143, United States

Location

Suite 101

St. Petersburg, Florida, 33710, United States

Location

Radiant Research

Stuart, Florida, 34996, United States

Location

Suite 203

Tampa, Florida, 33614, United States

Location

Boehringer Ingelheim Investigational Site

Zephyrhills, Florida, 33540, United States

Location

Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, 83814-2644, United States

Location

Suite 202

Idaho Falls, Idaho, 83404, United States

Location

Boehringer Ingelheim Investigational Site

Lake Forest, Illinois, 60045, United States

Location

Boehringer Ingelheim Investigational Site

Rockford, Illinois, 61103, United States

Location

Boehringer Ingelheim Investigational Site

Springfield, Illinois, 62704, United States

Location

Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Attn: Kathy Stoddard, Director

Wichita, Kansas, 67207, United States

Location

Suite 306

Wheaton, Maryland, 20902, United States

Location

Truesdale Clinic

Fall River, Massachusetts, 02720, United States

Location

Suite 202

Kalamazoo, Michigan, 49009, United States

Location

Suite 101

St Louis, Missouri, 63128, United States

Location

Suite 240

St Louis, Missouri, 63141, United States

Location

Boehringer Ingelheim Investigational Site

Lincoln, Nebraska, 68506, United States

Location

Boehringer Ingelheim Investigational Site

Reno, Nevada, 89502-1196, United States

Location

PC, Jackson Commons D-2

Medford, New Jersey, 08055, United States

Location

Suite 8

Mercerville, New Jersey, 08619, United States

Location

Boehringer Ingelheim Investigational Site

New York, New York, 10021, United States

Location

Suite 100

Charlotte, North Carolina, 28210, United States

Location

Boehringer Ingelheim Investigational Site

Columbus, Ohio, 43214, United States

Location

Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, 74135, United States

Location

Boehringer Ingelheim Investigational Site

Camp Hill, Pennsylvania, 17011, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, 16508-1256, United States

Location

Suite D

Mechanicsburg, Pennsylvania, 17055, United States

Location

Suite 331-333

Johnston, Rhode Island, 02919, United States

Location

Boehringer Ingelheim Investigational Site

Columbia, South Carolina, 29204, United States

Location

Suite H

North Charleston, South Carolina, 29406, United States

Location

Boehringer Ingelheim Investigational Site

Orangeburg, South Carolina, 29118, United States

Location

Boehringer Ingelheim Investigational Site

Austin, Texas, 78705, United States

Location

Boehringer Ingelheim Investigational Site

Dallas, Texas, 75225, United States

Location

Radiant Research

Dallas, Texas, 75231, United States

Location

Suite 200

Dallas, Texas, 75246-1632, United States

Location

Suite 500

Lubbock, Texas, 79410, United States

Location

Suites 207

San Antonio, Texas, 78217, United States

Location

Suite 2A

Falls Church, Virginia, 22044, United States

Location

Boehringer Ingelheim Investigational Site

Everett, Washington, 98201, United States

Location

Suite D-3

Seattle, Washington, 98166-2967, United States

Location

Boehringer Ingelheim Investigational Site

Yakima, Washington, 98902, United States

Location

Boehringer Ingelheim Investigational Site

Buenos Aires, 1405, Argentina

Location

Boehringer Ingelheim Investigational Site

Buenos Aires, 1427, Argentina

Location

Boehringer Ingelheim Investigational Site

Buenos Aires, 1428, Argentina

Location

Boehringer Ingelheim Investigational Site

Rosario, 2000, Argentina

Location

Boehringer Ingelheim Investigational Site

Cotton Tree, Queensland, 4558, Australia

Location

Emeritus Research

Malvern, Victoria, 3144, Australia

Location

Department of Rheumatology

Perth, Western Australia, 6004, Australia

Location

Clinique du Parc Léopold

Brussels, 1040, Belgium

Location

Medisch Centrum van Huisartsen

Leuven, 3000, Belgium

Location

Av Anhanguera 6479

Goiânia GO, 74043-011, Brazil

Location

Rua Ramiro Barcelos 2350

Porto Alegre RS, 90035-003, Brazil

Location

Boehringer Ingelheim Investigational Site

São Paulo - SP, 04040-000, Brazil

Location

Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

São Paulo - SP, 04230-000, Brazil

Location

230-6091

Richmond, British Columbia, V7C 5L9, Canada

Location

Boehringer Ingelheim Investigational Site

Victoria, British Columbia, V8P 5P6, Canada

Location

Boehringer Ingelheim Investigational Site

Corunna, Ontario, N0N 1G0, Canada

Location

Boehringer Ingelheim Investigational Site

Fort Erie, Ontario, L2A 1Z3, Canada

Location

Boehringer Ingelheim Investigational Site

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dr. Denis O'Donnell

Kingston, Ontario, K7L 2V6, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 4A2, Canada

Location

Boehringer Ingelheim Investigational Site

Ottawa, Ontario, K2P 1V3, Canada

Location

Boehringer Ingelheim Investigational Site

Peterborough, Ontario, K9J 7H8, Canada

Location

Boehringer Ingelheim Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, M1B 4Y9, Canada

Location

104-532

St. Catharines, Ontario, L2N 4H4, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M3B 2H9, Canada

Location

Boehringer Ingelheim Investigational Site

Windsor, Ontario, N8W 5L7, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H3Z, 2Z3, Canada

Location

Boehringer Ingelheim Investigational Site

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

Boehringer Ingelheim Investigational Site

Marseille, 13008, France

Location

Boehringer Ingelheim Investigational Site

Nice, 06000, France

Location

Boehringer Ingelheim Investigational Site

Tours, 37000, France

Location

Boehringer Ingelheim Investigational Site

Tours, 37044, France

Location

Boehringer Ingelheim Investigational Site

Aachen, 52064, Germany

Location

Augusta-Klinik

Bad Kreuznach, 55543, Germany

Location

Boehringer Ingelheim Investigational Site

Bad Segeberg, 23795, Germany

Location

Rheumatologie und Physikalische Therapie

Berlin, 14059, Germany

Location

Boehringer Ingelheim Investigational Site

Ellefeld, 08236, Germany

Location

Elisabeth-Krankenhaus

Essen, 45356, Germany

Location

Boehringer Ingelheim Investigational Site

Klotten, 56818, Germany

Location

ClinPharm International GmbH & Co. KG

Leipzig, 04229, Germany

Location

Boehringer Ingelheim Investigational Site

München, 81541, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90402, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90461, Germany

Location

Boehringer Ingelheim Investigational Site

Steinhöring, 85643, Germany

Location

Boehringer Ingelheim Investigational Site

Tübingen, 72070, Germany

Location

Klinik für Rheumatologie,

Wiesbaden, 65191, Germany

Location

National Institute for Rheumatology and Physiotherapy

Budapest, 1027, Hungary

Location

DOTE

Debrecen, 4031, Hungary

Location

Aladár Petz County Hospital

Győr, 9024, Hungary

Location

St. Andrew State Hospital

Hévíz, 8380, Hungary

Location

St. Ferenc Hospital

Miskolc, 3501, Hungary

Location

Pál Almási Balogh Hospital

Ózd, 3601, Hungary

Location

Hungarian Brothers of St. John of Good

Pécs, 7621, Hungary

Location

Szegedi University

Szeged, 6720, Hungary

Location

Ferenc Csolnoky County Hospital

Veszprém, 8201, Hungary

Location

Università degli Studi

Genova, Italy

Location

Ospedale Augusto Murri

Iesi, 60035, Italy

Location

Università degli Studi di Napoli "Federico II"

Napoli, 80131, Italy

Location

Ospedale A. Galateo

SAN Cesario (Lecce), 73016, Italy

Location

Institute of Rheumatology of RAMN

Moscow, 115522, Russia

Location

City Clinical Hospital No. 1

Moscow, 117049, Russia

Location

896 Pyung Chon-Dong, Dongan-Gu

Gyeonggi-do, 431-070, South Korea

Location

San-5, Woncheon-Dong, Paldal-Gu

Gyeonggi-do, 442-721, South Korea

Location

85 Jeo-Dong 2Ga

Seoul, 100-032, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Boehringer Ingelheim Investigational Site

Seoul, 120-752, South Korea

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Rheumatology-Allergy-Immunology

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Dnyepropyetrovsk Medical Academy

Dnyepropetrovsk, 49044, Ukraine

Location

Central City Hospital

Donetsk, 83098, Ukraine

Location

State Medical University

Donetsk, 83114, Ukraine

Location

Municipal Institute of Health Care

Kharkiv, 61091, Ukraine

Location

City Multitype Clinical Hospital No. 25

Kharkiv, 61115, Ukraine

Location

Central Clinical Hospital

Kiev, 01023, Ukraine

Location

Institute of Cardiology

Kiev, 03151, Ukraine

Location

Regional Hospital No. 1

Kiev, 04107, Ukraine

Location

Institute of Gerontology

Kyiv, 04114, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Ltd./Bracknell

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2002
• First Posted: July 24, 2002
• Study Start: June 1, 2002
• Study Completion: July 1, 2003
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

TW (4); AU (3); CA (17); UA (9); US (72); BE (2); BR (4); AR (4); IT (4); KR (5); FR (4); DE (14); HU (9); RU (2)