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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.
Sponsored by: 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

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Meloxicam
U.S. FDA Resources
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

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

  Show 153 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 107.258
Study First Received: July 22, 2002
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00042068  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Meloxicam
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on January 13, 2009