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Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Osteoarthritis

Arthritis, Rheumatoid

Eligibility:

All Genders

18+ years

Brief Summary

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 Medi...

Eligibility Criteria

Inclusion

  • 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) ):
  • Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs
  • Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs
  • Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months
  • Severe liver failure
  • Non-dialysed severe renal failure
  • Pregnancy or breastfeeding
  • Haemostasis disorders or concomitant treatment with anticoagulants
  • Severe congestive heart failure

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    3569 Patients enrolled

    Trial Details

    Trial ID

    NCT00619177

    Start Date

    March 1 2007

    Last Update

    February 16 2015

    Active Locations (319)

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    Page 1 of 80 (319 locations)

    1

    Boehringer Ingelheim Investigational Site

    Split, Croatia

    2

    Boehringer Ingelheim Investigational Site

    Zagreb, Croatia

    3

    Boehringer Ingelheim Investigational Site

    Aš, Czechia

    4

    Boehringer Ingelheim Investigational Site

    Babice, Czechia