Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life
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Purpose
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.
| Condition |
|---|
|
Osteoarthritis Arthritis, Rheumatoid |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessing the Impact of MOVALIS on Health Related Quality of Life |
- 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)
- 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.
| Enrollment: | 3569 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
primary care and rheumatology clinics
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
Contacts and Locations
Show 320 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00619177 History of Changes |
| Other Study ID Numbers: | 107.273 |
| Study First Received: | February 8, 2008 |
| Results First Received: | May 22, 2009 |
| Last Updated: | May 11, 2012 |
| Health Authority: | Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Estonia: State Agency of Medicines, EE-5041Tartu Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013