Clinical trial NCT04099459: ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
Official title: ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Lead sponsor: Scandinavia Pharma
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 1250
Sex: ALL
Minimum age (years): 38
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Presence of risk factors for adverse events associated to consumption of NSAIDs
timeFrame: 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
Secondary outcomes:
measure: Demographic analysis
timeFrame: 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
measure: List of drugs used (by the patient) for treatment of osteoarthritis (OA)
timeFrame: 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
measure: Evaluation of the current state of the disease according to functional limitation and pain
timeFrame: 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
measure: Adverse Events related with the treatments
timeFrame: 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
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Scandinavia Pharma
Study officials:
affiliation: Medical Director
name: Javier Castillo, Dr
role: STUDY_DIRECTOR
References: