Clinical trial: A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis (NCT00239395)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female aged 18 years or above

          -  Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or
             knee.

        The diagnosis must be based on

          -  clinical signs and symptoms or

          -  x-ray diagnosis plus clinical signs and symptoms

               -  Assessment of pain on active movement (by the patient) must exceed 40 mm on a 100
                  mm visual analogue scale (VAS)

               -  Symptoms of OA requiring administration of NSAIDs

               -  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 last six 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 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

          -  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 transferase
             (AST/SGOT) and/or alkaline transferase (ALT/SGPT) 200 % of the upper limit of normal
             range

          -  Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3

          -  Synovectomy in the previous month or during the trial

          -  Participation in another clinical trial during this study or during the previous month

          -  Previous participation in this trial

          -  Patient unable to comply with the protocol

          -  Concomitant therapy with specific symptomatic drug of OA, such as chondroitin
             sulphate, diacerhein, initiated or with an altered dose over the previous 3 months.

          -  Intraarticular administration of hyaluronic acid in the previous month

          -  Patients where physiotherapy will be changed throughout the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment