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
- NCT00042068
- PHASE3
- INTERVENTIONAL
Last updated: 2013-11-01
Purpose of Trial
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.
This study is for people with
Arthritis, Rheumatoid
Interventions being studied
Meloxicam
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
72 Locations
Huntsville
Suites 570 (research) & 600 (PI)
Alabama, 35801, United States
Montgomery
Suite 200
Alabama, 36106, United States
Anchorage
Suite 140
Alaska, 99508, United States
Glendale
#106
Arizona, 85308, United States
Phoenix
Suite 601
Arizona, 85012, United States
Phoenix
Suite 201
Arizona, 85015, United States
Los Angeles
Boehringer Ingelheim Investigational Site
California, 90048, United States
Pasadena
Boehringer Ingelheim Investigational Site
California, 91105, United States
Rancho Cucamonga
Suite 100
California, 91730, United States
Rancho Mirage
Boehringer Ingelheim Investigational Site
California, 92270-4469, United States
San Diego
Suite 208
California, 92108, United States
San Diego
Suite 202
California, 92120, United States
San Leandro
Suite 301
California, 94578, United States
Santa Maria
Suite A
California, 93454, United States
Westlake Village
Westlake Medical Research
California, 91361, United States
Colorado Springs
Suite 200
Colorado, 80910, United States
Danbury
Suites 205 & 206
Connecticut, 06810, United States
Washington
Suite 300
District of Columbia, 20006, United States
Del Ray Beach
Boehringer Ingelheim Investigational Site
Florida, 33484, United States
Gainsville
Boehringer Ingelheim Investigational Site
Florida, 32607, United States
Jacksonville
Boehringer Ingelheim Investigational Site
Florida, 32204, United States
Largo
Boehringer Ingelheim Investigational Site
Florida, 33773, United States
Miami
Suite 202
Florida, 33173, United States
Ocala
Boehringer Ingelheim Investigational Site
Florida, 03474, United States
Ocala
Renstar Medical Research
Florida, 34471, United States
Orlando
Boehringer Ingelheim Investigational Site
Florida, 32804, United States
Orlando
Suite 2
Florida, 32806, United States
Safety Harbor
Suite 406
Florida, 34695, United States
Sarasota
Boehringer Ingelheim Investigational Site
Florida, 34239, United States
South Miami
Boehringer Ingelheim Investigational Site
Florida, 33143, United States
St. Petersburg
Suite 101
Florida, 33710, United States
Stuart
Radiant Research
Florida, 34996, United States
Tampa
Suite 203
Florida, 33614, United States
Zephyrhills
Boehringer Ingelheim Investigational Site
Florida, 33540, United States
Coeur d'Alene
Boehringer Ingelheim Investigational Site
Idaho, 83814-2644, United States
Idaho Falls
Suite 202
Idaho, 83404, United States
Lake Forest
Boehringer Ingelheim Investigational Site
Illinois, 60045, United States
Rockford
Boehringer Ingelheim Investigational Site
Illinois, 61103, United States
Springfield
Boehringer Ingelheim Investigational Site
Illinois, 62704, United States
Indianapolis
Boehringer Ingelheim Investigational Site
Indiana, 46202, United States
Wichita
Attn: Kathy Stoddard, Director
Kansas, 67207, United States
Wheaton
Suite 306
Maryland, 20902, United States
Fall River
Truesdale Clinic
Massachusetts, 02720, United States
Kalamazoo
Suite 202
Michigan, 49009, United States
St. Louis
Suite 101
Missouri, 63128, United States
St. Louis
Suite 240
Missouri, 63141, United States
Lincoln
Boehringer Ingelheim Investigational Site
Nebraska, 68506, United States
Reno
Boehringer Ingelheim Investigational Site
Nevada, 89502-1196, United States
Medford
PC, Jackson Commons D-2
New Jersey, 08055, United States
Mercerville
Suite 8
New Jersey, 08619, United States
New York
Boehringer Ingelheim Investigational Site
New York, 10021, United States
Charlotte
Suite 100
North Carolina, 28210, United States
Columbus
Boehringer Ingelheim Investigational Site
Ohio, 43214, United States
Tulsa
Boehringer Ingelheim Investigational Site
Oklahoma, 74135, United States
Camp Hill
Boehringer Ingelheim Investigational Site
Pennsylvania, 17011, United States
Duncansville
Altoona Center for Clinical Research
Pennsylvania, 16635, United States
Erie
Boehringer Ingelheim Investigational Site
Pennsylvania, 16508-1256, United States
Mechanicsburg
Suite D
Pennsylvania, 17055, United States
Johnston
Suite 331-333
Rhode Island, 02919, United States
Columbia
Boehringer Ingelheim Investigational Site
South Carolina, 29204, United States
North Charleston
Suite H
South Carolina, 29406, United States
Orangeburg
Boehringer Ingelheim Investigational Site
South Carolina, 29118, United States
Austin
Boehringer Ingelheim Investigational Site
Texas, 78705, United States
Dallas
Boehringer Ingelheim Investigational Site
Texas, 75225, United States
Dallas
Radiant Research
Texas, 75231, United States
Dallas
Suite 200
Texas, 75246-1632, United States
Lubbock
Suite 500
Texas, 79410, United States
San Antonio
Suites 207
Texas, 78217, United States
Falls Church
Suite 2A
Virginia, 22044, United States
Everett
Boehringer Ingelheim Investigational Site
Washington, 98201, United States
Seattle
Suite D-3
Washington, 98166-2967, United States
Yakima
Boehringer Ingelheim Investigational Site
Washington, 98902, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov