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 therapy on HRQoL in the diverse region of Central and Eastern Europe. The SF-12v2 will be used as the instrument to measure any change in physical wellbeing (PCS) and mental wellbeing (MCS) of patients following MOVALIS therapy.

Study Type: Observational

Study Design: N/A

Study Primary Completion Date: May 2008

Inclusion Criteria:

Inclusion Criteria (according to 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 COX-2 inhibitor in the previous 7 days
• 7. Pain intensity on the visual analogue scale (VAS) 25 mm and above

Exclusion Criteria:

Exclusion Criteria (according to contraindications of 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 Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

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