A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
Completed · Phase 3
Conditions studied: Arthritis, Rheumatoid
In brief
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.
Key facts
- Study ID
- NCT00042068
- Run by
- Boehringer Ingelheim
- People needed
- 1000
- Starts
- 2002-06-01
- Expected to finish
- 2003-07-01
- Last updated by the study team
- 2013-11-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Suite 200 — Montgomery, Alabama, United States
- Suite 140 — Anchorage, Alaska, United States
- #106 — Glendale, Arizona, United States
- Suite 601 — Phoenix, Arizona, United States
- Suite 201 — Phoenix, Arizona, United States
- Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
- Boehringer Ingelheim Investigational Site — Pasadena, California, United States
- Suite 100 — Rancho Cucamonga, California, United States
- Boehringer Ingelheim Investigational Site — Rancho Mirage, California, United States
- Suite 208 — San Diego, California, United States
- Suite 202 — San Diego, California, United States
- Suite 301 — San Leandro, California, United States
- Suite A — Santa Maria, California, United States
- Westlake Medical Research — Westlake Village, California, United States
- Suite 200 — Colorado Springs, Colorado, United States
- Suites 205 & 206 — Danbury, Connecticut, United States
- Suite 300 — Washington D.C., District of Columbia, United States
- Boehringer Ingelheim Investigational Site — Delray Beach, Florida, United States
- Boehringer Ingelheim Investigational Site — Gainsville, Florida, United States
- Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
- Boehringer Ingelheim Investigational Site — Largo, Florida, United States
- Suite 202 — Miami, Florida, United States
- Boehringer Ingelheim Investigational Site — Ocala, Florida, United States
- Renstar Medical Research — Ocala, Florida, United States
- Suites 570 (research) & 600 (PI) — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.