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

This study has been completed.

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	Phase
Osteoarthritis Rheumatoid Arthritis	Phase IV

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Meloxicam

U.S. FDA Resources

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	4150
Estimated Study Completion Date:	September 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (according to SPC):

Male or female patients aged 18 years or above
Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control)
Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis
Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Patients requiring either parenteral and/or oral NSAIDs
Patients who have not taken another NSAID or 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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619177

Show 318 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

BI Pharma Ges mbH Wien

More Information

Study ID Numbers:	107.273
Study First Received:	February 8, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00619177
Health Authority:	Austria: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Austria: Croatian Institute for Medicines Control, HR-10000 Zagreb; Austria: State Agency of Medicines, EE-5041Tartu; Austria: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Austria: 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:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009