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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034853 |
Purpose
Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Juvenile Rheumatoid |
Drug: meloxicam oral suspension Drug: naproxen oral suspension |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208) |
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2000 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| 107.235.23 Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| 107.235.17 Valley Children's Hospital | |
| Madera, California, United States | |
| 107.235.37 | |
| San Diego, California, United States | |
| United States, Colorado | |
| 107.235.4 Boehringer Ingelheim Investigational Site | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| 107.235.12 Boehringer Ingelheim Investigational Site | |
| Hartford, Connecticut, United States | |
| United States, Delaware | |
| 107.235.13 Alfred I. DuPont Hospital for Children | |
| Wilmington, Delaware, United States | |
| United States, Florida | |
| 107.235.36 Arthritis Associates Clinical Research of South Florida | |
| Del Ray Beach, Florida, United States | |
| 107.235.21 Miami Children's Hospital | |
| Miami, Florida, United States | |
| 107.235.38 Clinical Research Dept #7006 | |
| St. Petersberg, Florida, United States | |
| United States, Illinois | |
| 107.235.8 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Kansas | |
| 107.235.7 Boehringer Ingelheim Investigational Site | |
| Kansas City, Kansas, United States | |
| United States, Kentucky | |
| 107.235.25 University of Louisville | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| 107.235.16 Children's Hospital - Department of Rheumatology | |
| New Orleans, Louisiana, United States | |
| United States, Massachusetts | |
| 107.235.26 Deparment of Rheumatology | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| 107.235.2 E15 Mayo Clinic | |
| Rochester, Minnesota, United States | |
| United States, Missouri | |
| 107.235.18 Washington University School of Medicine | |
| St. Louis, Missouri, United States | |
| 107.235.9 Boehringer Ingelheim Investigational Site | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| 107.235.31 Department of Pediatrics | |
| Omaha, Nebraska, United States | |
| United States, New Jersey | |
| 107.235.35 Arthritis and Rheumatic Disease Center | |
| Livingston, New Jersey, United States | |
| United States, New York | |
| 107.235.19 Columbia Presbyterian Medical Center | |
| New York, New York, United States | |
| 107.235.24 The Children's Hospital of Buffalo | |
| Buffalo, New York, United States | |
| United States, Oklahoma | |
| 107.235.33 Healthcare Research Consultants | |
| Tulsa, Oklahoma, United States | |
| 107.235.22 Oklahoma Medical Research Foundation | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| 107.235.32 Arthritis and Osteoporosis Center | |
| Duncansville, Pennsylvania, United States | |
| United States, Rhode Island | |
| 107.235.39 Division of Ambulatory Pediatrics | |
| Providence, Rhode Island, United States | |
| United States, Texas | |
| 107.235.10 Texas Scottish Rite Hospital | |
| Dallas, Texas, United States | |
| United States, Utah | |
| 107.235.1 University of Utah School of Medicine | |
| Salt Lake CIty, Utah, United States | |
| United States, Washington | |
| 107.235.30 Children's Hospital | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| 107.235.20 Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States | |
| Brazil | |
| 107.235.60 | |
| Sao Paulo, Brazil | |
| 107.235.61 | |
| Cerqueira César, Brazil | |
| 107.235.62 | |
| Santa Cecília, Brazil | |
| Mexico | |
| 107.235.40 | |
| México, D.F., Mexico | |
| Ukraine | |
| 107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT" | |
| Kiev, Ukraine | |
| 107.235.71 Institute of Children and Adolescents Health | |
| Kharkov, Ukraine | |
| 107.235.72 Institute of Pediatrics | |
| Kiev, Ukraine | |
| 107.235.70 Children Clinical Hospital No. 1 | |
| Kiev, Ukraine | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 107.235 |
| Study First Received: | May 2, 2002 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00034853 History of Changes |
| Health Authority: | Argentina: Ministry of Health; Brazil: Ministry of Health; Mexico: Ministry of Health; Ukraine: Ministry of Health; United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Arthritis, Rheumatoid Gout Suppressants Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Naproxen |
Autoimmune Diseases Arthritis, Juvenile Rheumatoid Immune System Diseases Joint Diseases Meloxicam Cyclooxygenase Inhibitors Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |