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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.
Study NCT00042068   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: July 22, 2002   Last Updated: September 24, 2009   History of Changes

July 22, 2002
September 24, 2009
June 2002
 
 
 
Complete list of historical versions of study NCT00042068 on ClinicalTrials.gov Archive Site
 
 
 
A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
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

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.

 
Phase III
Interventional
Randomized, Double-Blind, Placebo Control, Parallel Assignment
Arthritis, Rheumatoid
Drug: Meloxicam
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1000
July 2003
 

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Russian Federation,   Taiwan,   Ukraine
 
NCT00042068
 
107.258
Boehringer Ingelheim Pharmaceuticals
 
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
Boehringer Ingelheim Pharmaceuticals
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP