ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs

• Conditions: Osteoarthritis

• Registration Number: NCT04099459
• Lead Sponsor: Scandinavia Pharma

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.

Study Timeline

• Study Start: 2019-06-10
• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-23
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of risk factors for adverse events associated to consumption of NSAIDs	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.

Secondary Outcome Measures

Name	Time	Method
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	List of drugs used (by the patient) for treatment of osteoarthritis (OA), including time of use and posology.
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	Evaluation of functional limitation and pain according to the Visual Analogue Scale graduated between 0 and 10, being 0 absence or asymptomatic and 10 the maximum pain or maximum functional limitation.
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	Characterization of patients
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	Evaluation of Adverse events associated with the treatment (s)

Trial Locations

Locations (1)

Scandinavia Pharma; 🇨🇴 Bogotá, Colombia