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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00619177
First received: February 8, 2008
Last updated: May 11, 2012
Last verified: May 2012

February 8, 2008
May 11, 2012
March 2007
May 2008   (final data collection date for primary outcome measure)
  • 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) ]
    Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
  • 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) ]
    Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
The primary endpoint is the difference in SF12 scores between visit 1 (day 0) and visit 2 (approx. day 28). The SF12 enables the effect on physical wellbeing (SF12 PCS) and mental wellbeing (SF12 MCS) to be evaluated separately. [ Time Frame: 4 Weeks ]
Complete list of historical versions of study NCT00619177 on ClinicalTrials.gov Archive Site
  • Change From Baseline of Pain Intensity on Visual Analogue Scale [ Time Frame: Approximately four weeks of treatment ]
    The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)
  • Patient Assessment of Efficacy [ Time Frame: after approximately 4 weeks of treatment ]

    Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.

    The patients have been placed into categories according to the points on a scale.

  • Physician Assessment of Efficacy [ Time Frame: after approximately 4 weeks of treatment ]

    Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.

    The patients have been placed into categories according to the points on a scale.

An overall assessment of pain intensity measured by visual analogue scale (VAS ranging from no pain to severe pain). Physicians and patients assessment of MOVALIS efficacy on 5 point scale (excellent, very good, good, fair, and poor) [ Time Frame: 4 Weeks ]
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Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

primary care and rheumatology clinics

  • Osteoarthritis
  • Arthritis, Rheumatoid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3569
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May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Czech Republic,   Estonia,   Russian Federation,   Slovakia
 
NCT00619177
107.273
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Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP