A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis
Arthritis, Rheumatoid
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 years or above The patient has rheumatoid arthritis, as defined by the American Rheumatism Association. Assessment of overall pain (by the patient), after a washout for NSAID of at least 2 days (3 days for oxicams), must exceed 40 mm on a 100 mm visual analogue scale (VAS) Symptoms of RA requiring administration of NSAIDs Outpatients Willingness and ability to provide written informed consent. Exclusion Criteria: Known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDs Any clinical evidence of active peptic ulceration during the previous 6 months Pregnancy or breastfeeding (precaution: attention should be drawn to reports that NSAIDs were reported to decrease the effectivity of intrauterine devices) Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs Concomitant treatment with anti-coagulants (including heparin), lithium Concomitant administration of other NSAIDs or analgesic agents (except paracetamol up to 4g/day) Administration of any NSAID during the last 2 days (3 days for any oxicam) prior to the first administration of the trial drug Concomitant treatment with methotrexate, sulfasalazine, D-penicillamine, chloroquine or any other disease modifying antirheumatic drug initiated or with an altered dose over the previous 3 months Concomitant treatment with an oral corticosteroid initiated or with an altered dose over the previous month Parenteral or intraarticular administration of corticosteroids in the previous month Any i.m. injection during the previous 7 days Synovectomy and/or surgical treatment for RA in the previous month or during the trial Any physiotherapy which will be changed during the trial Any contra-indication to i.m. injections Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance, ulcerative colitis Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety Serum creatinine 125 % of the upper limit of normal range ; aspartate amino-transferase (AST/SGOT) and/or alaline amino-transferase (ALT/SGPT) 200 % of the upper limit of normal range Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3 Participation in another clinical trial during this study or during the previous month Previous participation in this trial (i.e. having been allocated a randomized treatment number) Patient unable to comply with the protocol
Sites / Locations
- People's Hospital, Beijing University
- Beijing Xuan Wu Hospital
- 1st Affiliated, Anhui Medical University
- Qilu Hospital, Shang Dong University
- Shanghai Renji Hospital
- Shanghai Zhongshan Hospital
- Shanghai Guanghai Hospital
- Shanghai Changhai Hospital