Arthritis, Rheumatoid
Conditions
Brief summary
The objective of this trial was to assess the efficacy and safety of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with Rheumatoid arthritis over a time period of 7 days.
Detailed description
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 15 mg meloxicam i.m. once daily compared with 15 mg meloxicam tablets once daily p.o. in patients with rheumatoid arthritis over a time period of 7 days. Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet). The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's assessment of overall pain | 7 days |
| Patient's global assessment of disease activity | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Swollen Joint Count | 7 days |
| Duration of Morning Stiffness | 7 days |
| Patient's assessment of physical function | 7 days |
| Final Global Assessment of Efficacy by Patient | 7 days |
| Final Global Assessment of Efficacy by Investigator | 7 days |
| Investigator's Global Assessment of Disease Activity | 7 days |
| Change in Patient Status With Regard to Arthritic Condition as Assessed by the Patient | 7 days |
| Change in Patient Status With Regard to Arthritic Condition as Assessed by the Investigator | 7 days |
| Onset of Analgesic Action | 7 days |
| Time to Maximum Pain Relief After the First Trial Drug Administration | 7 days |
| Paracetamol Consumption | 7 days |
| Withdrawals due to Inadequate Efficacy | 7 days |
| Tender/Painful Joint Count | 7 days |
Countries
China
Outcome results
None listed