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

Completed
Conditions
Osteoarthritis
Arthritis, Rheumatoid
Registration Number
NCT00619177
Lead Sponsor
Boehringer Ingelheim
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3569
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.baseline and final visit (approximately 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 2Baseline 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)

Secondary Outcome Measures
NameTimeMethod
Change From Baseline of Pain Intensity on Visual Analogue ScaleApproximately 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 Efficacyafter 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 Efficacyafter 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.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site

🇸🇰

Zilina, Slovakia

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