Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life
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| Tracking Information | |||||
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| First Received Date ICMJE | February 8, 2008 | ||||
| Last Updated Date | May 11, 2012 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00619177 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life | ||||
| Official Title ICMJE | Assessing the Impact of MOVALIS on Health Related Quality of Life | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | primary care and rheumatology clinics |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 3569 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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) ):
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Croatia, Czech Republic, Estonia, Russian Federation, Slovakia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00619177 | ||||
| Other Study ID Numbers ICMJE | 107.273 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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