A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Meloxicam

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