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Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life
This study has been completed.
First Received: February 8, 2008   Last Updated: February 12, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00619177
  Purpose

The objective of the observational study is to examine the effect of MOVALIS therapy on HRQoL in the diverse region of Central and Eastern Europe. The SF-12v2 will be used as the instrument to measure any change in physical wellbeing (PCS) and mental wellbeing (MCS) of patients following MOVALIS therapy.


Condition
Osteoarthritis
Arthritis, Rheumatoid

Study Type: Observational
Official Title: Assessing the Impact of MOVALIS on Health Related Quality of Life

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 3531
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
Criteria

Inclusion Criteria:

Inclusion Criteria (according to 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 COX-2 inhibitor in the previous 7 days
  7. Pain intensity on the visual analogue scale (VAS) 25 mm and above

Exclusion Criteria:

Exclusion Criteria (according to contraindications of 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619177

  Show 320 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 107.273
Study First Received: February 8, 2008
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00619177     History of Changes
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

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Meloxicam
Connective Tissue Diseases
Arthritis, Rheumatoid
Quality of Life
Rheumatic Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009