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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.
Information provided by:
Boehringer Ingelheim Identifier:
First received: July 22, 2002
Last updated: October 31, 2013
Last verified: October 2013
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Response according to American College of Rheumatology 20% (ACR20) classification [ Time Frame: at 12 weeks ]

Secondary Outcome Measures:
  • Number of painful or tender joints [ Time Frame: up to 12 weeks ]
  • Number of swollen joints [ Time Frame: up to 12 weeks ]
  • Patient's global (overall) assessment of disease activity [ Time Frame: up to 12 weeks ]
  • Investigator's global (overall) assessment of disease activity [ Time Frame: up to 12 weeks ]
  • Patient's assessment of pain [ Time Frame: up to 12 weeks ]
  • Patient's assessment of physical function (mHAQ) [ Time Frame: up to 12 weeks ]
  • C-Reactive Protein (CRP) [ Time Frame: up to 12 weeks ]
  • Withdrawal due to lack of efficacy [ Time Frame: up to 12 weeks ]
  • Duration of morning stiffness [ Time Frame: up to of 12 weeks ]
  • Patient's final global (overall) assessment of efficacy [ Time Frame: at end of 12 weeks ]
  • Investigator's final global (overall) assessment of efficacy [ Time Frame: at end of 12 weeks ]
  • Patient status with regard to change in arthritic condition [ Time Frame: at end of 12 weeks ]
  • Use of rescue medication [ Time Frame: up to 12 weeks ]
  • Incidence and intensity of adverse events [ Time Frame: until 4 weeks post treatment ]
  • Patient's final global assessment of tolerability [ Time Frame: at end of 12 weeks ]
  • Investigator's final global assessment of tolerability [ Time Frame: at end of 12 weeks ]
  • Withdrawals due to adverse events [ Time Frame: at end of 12 weeks ]

Estimated Enrollment: 1000
Study Start Date: June 2002
Estimated Study Completion Date: July 2003

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00042068

  Show 153 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
  More Information Identifier: NCT00042068     History of Changes
Other Study ID Numbers: 107.258
Study First Received: July 22, 2002
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017