Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life

Official Title: “Assessing the Impact of MOVALIS on Health Related Quality of Life”

The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.

Primary Measures

• Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.
  • Time Frame: baseline and final visit (approximaly 4 weeks)
    
• Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2
  • Time Frame: Baseline and final visit (approximately 4 weeks)
    

Secondary Measures

• Change From Baseline of Pain Intensity on Visual Analogue Scale
  • Time Frame: Approximately four weeks of treatment
    
• Patient Assessment of Efficacy
  • Time Frame: after approximately 4 weeks of treatment
    
• Physician Assessment of Efficacy
  • Time Frame: after approximately 4 weeks of treatment
    

Inclusion Criteria (according to Summary of Product Characteristics (SPC) ):

• 1. Male or female patients aged 18 years or above 2 Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control) 3. Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis 4. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 5. Patients requiring either parenteral and/or oral NSAIDs 6. Patients who have not taken another
• NSAID or Cyclo-oxygenase-2 (COX-2) inhibitor in the previous 7 days Pain intensity on the visual analogue scale (VAS) 25 mm and above
• Exclusion Criteria (according to contraindications of Summary of Product Characteristics (SPC) ):
• 1. Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs
• 2. Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs
• 3. Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months
• 4. Severe liver failure
• 5. Non-dialysed severe renal failure
• 6. Pregnancy or breastfeeding
• 7. Haemostasis disorders or concomitant treatment with anticoagulants
• 8. Severe congestive heart failure

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619177

Study ID Number: 107.273

ClinicalTrials.gov Identifier: NCT00619177

Health Authority: Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb