Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS). (RATIONAL)
|ClinicalTrials.gov Identifier: NCT01577563|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : May 14, 2013
|Condition or disease|
|Osteoarthritis (OA) Rheumatoid Arthritis (RA) Ankylosing Spondylitis (AS)|
|Study Type :||Observational|
|Actual Enrollment :||5383 participants|
|Official Title:||Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis Receiving Treatment With Non- Steroidal Anti- Inflammatory Drugs.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
U.S. FDA Resources
- Number of subject with age above 60 years. [ Time Frame: Up to 4 weeks. ]
- Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs. [ Time Frame: Up to 4 weeks. ]
- Number of patients with previous ulcer history. [ Time Frame: Up to 4 weeks. ]
- Number of patients with previous ulcer bleeding history. [ Time Frame: Up to 4 weeks. ]
- Number of patients with history of dyspepsia. [ Time Frame: Up to 4 weeks. ]
- Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status. [ Time Frame: Up to 4 weeks. ]
- Descriptive profile of medical history: nicotine use, relevant medical conditions, history peptic ulcer, chronic drug therapy related to relevant medical conditions. [ Time Frame: Up to 4 weeks. ]
- Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI. [ Time Frame: Up to 4 weeks. ]
- Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis. [ Time Frame: Up to 4 weeks. ]
- Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications. [ Time Frame: Up to 4 weeks. ]
- Gastrointestinal Symptoms Rating Scale (GSRS). [ Time Frame: Up to 4 weeks. ]Rating scale for gastrointestinal symptoms in patients, consisting of five areas: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome.
- Treatment Satisfaction for medication for OA patients (TSQM). [ Time Frame: Up to 4 weeks. ]Assessment of patients' satisfaction with medication, providing scores on four scales: side effects, effectiveness, convenience and global satisfaction.
- Treatment adherence (Morisky Medication Assessment Scale- MMAs-4). [ Time Frame: Up to 4 weeks. ]A generic self-reported, medication-taking behaviour scale in which the specific health issue (e.g. rheumatic pain and dyspepsia) is inserted for the "health concern". The MMAS-4 consists of four items with a scoring scheme of "Yes" = 0 and "No" = 1. The items are added together to give a range of scores from low adherence to high adherence (0 to 4).
- Patient Quality of Life (EQ-5D). [ Time Frame: Up to 4 weeks. ]The questionnaire consists of 2 aspects: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems and severe problems.
- Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1). [ Time Frame: Up to 4 weeks. ]Osteoarthritis Index, self-administered, to report health status which is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
- Health Assessment Questionnaire (HAQ). [ Time Frame: Up to 4 weeks. ]Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577563
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|Study Chair:||Gustavo Citera, Rheumatologist||Universidad Nacional de Buenos Aires. Argentina|