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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00619177 |
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Date of registration:
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08/02/2008 |
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Primary sponsor: |
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Public title:
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Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life
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Scientific title:
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Assessing the Impact of MOVALIS on Health Related Quality of Life |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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3569 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00619177 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Croatia
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Czech Republic
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Estonia
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Russian Federation
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Slovakia
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Osteoarthritis
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Primary Outcome(s)
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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)]
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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)]
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Secondary Outcome(s)
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Change From Baseline of Pain Intensity on Visual Analogue Scale
[Time Frame: Approximately four weeks of treatment]
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Patient Assessment of Efficacy
[Time Frame: after approximately 4 weeks of treatment]
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Physician Assessment of Efficacy
[Time Frame: after approximately 4 weeks of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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