Status:
COMPLETED
A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 31 2004
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00239382
Start Date
July 1 2004
End Date
December 31 2004
Last Update
August 3 2018
Active Locations (8)
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1
People's Hospital, Beijing University
Beijing, China, 100044
2
Beijing Xuan Wu Hospital
Beijing, China, 100050
3
1st Affiliated, Anhui Medical University
Hefei City, Anhui Province, China, 230022
4
Qilu Hospital, Shang Dong University
Nanzhou, China, 250012