ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Presence of risk factors for adverse events associated to consumption of NSAIDs
研究概览
简要总结
Cross-sectional epidemiological study in patients with diagnosis of osteoarthritis (OA) in order to evaluate risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID).
详细描述
OBJECTIVE
To evaluate the presence of risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID) in patients diagnosed with osteoarthritis (OA).
MATERIALS AND METHODS
A multicentric, cross-sectional epidemiological study, will be carried out in patients ≥ 38 years of age, with a previous diagnosis of primary or secondary OA, according to criteria of the American College of Rheumatology (ACR). The presence of at least one risk factor for the use / prescription of NSAIDs is the main variable. The secondary variables to be evaluated include: Demographical characterization of the patients, current disease status (level of pain and functional limitation), treatment (s) used (related or not to OA) and events side effects associated with the treatment (s). The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 38 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 38 years
- •Previous diagnosis of OSTEOARTRITIS (primary or secondary) at least 30 days before or more, in at least one or more of the following locations: Knee and / or Hip and / or Hand, according to criteria of the American College of Rheumatology (ACR)
排除标准
- •Refusal to participate in the study by the patient.
- •Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.
- •Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.
结局指标
主要结局
Presence of risk factors for adverse events associated to consumption of NSAIDs
时间窗: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
A descriptive analysis about presence of risk factors for the possible ocurrence of adverse events associated to consumption of NSAIDs in the patients: gastrointestinal, renal, cardiovascular.
次要结局
- List of drugs used (by the patient) for treatment of osteoarthritis (OA)(It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years)
- Evaluation of the current state of the disease according to functional limitation and pain(It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years)
- Demographic analysis(It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years)
- Adverse Events related with the treatments(It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years)