A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA.

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Meloxicam ampoule
* Drug: Meloxicam tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Meloxicam ampoule|nan|
|Drug: Meloxicam tablet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's assessment of overall pain |  | 7 days | 
| Patient's global assessment of disease activity |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment of Disease Activity |  | 7 days | 
| Tender/Painful Joint Count |  | 7 days | 
| 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 | 
| Withdrawals due to Inadequate Efficacy |  | 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 |