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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00042068Tipo: INTERVENTIONALInicio: 1 de jun de 2002Fin estimado: 1 de jul de 2003

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Meloxicam

Ubicaciones

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

Patrocinadores

PrincipalBoehringer Ingelheim

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