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Tracking Information | |||||
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First Received Date † | May 2, 2002 | ||||
Last Updated Date | March 27, 2006 | ||||
Start Date † | December 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00034853 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Meloxicam Suspension in Juvenile Rheumatoid Arthritis (JRA) | ||||
Official Title † | A 12 Wk Double-Blind Randomized Trial, With a 12 Wk Open-Label Extension, to Investigate Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With JRA. | ||||
Brief Summary | The purpose of this 6 month study is to determine how safe and effective meloxicam oral suspension (liquid taken by mouth) is in children with JRA. |
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Detailed Description | The primary aim of this trial is to compare the efficacy and safety of several doses of meloxicam oral suspension (0.125 mg/kg and 0.25 mg/kg with a 0.125 mg/kg dose escalation at 4 weeks) administered once daily with naproxen oral suspension (10 mg/kg with a dose escalation to15 mg/kg at 4 weeks administered in divided doses twice daily) over a period of 12 weeks in the treatment of patients with JRA. The 12-week double-blind portion of the trial is followed by an open-label extension of meloxicam oral suspension at 0.375 mg/kg/day to obtain additional safety information. A subgroup of patients will participate in a pharmacokinetic study at the conclusion of the open label extension phase. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Juvenile Rheumatoid Arthritis | ||||
Intervention † | Drug: Meloxicam | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 180 | ||||
Completion Date | June 2003 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Years to 17 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Argentina, Brazil, Mexico | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00034853 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
Verification Date | September 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |