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

Osteoarthritis Clinical Trial

— ORCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04099459
• Other study ID #: ORCA
• Status: Recruiting
• Start date: June 10, 2019
• Est. completion date: July 2024

Study information

• Verified date: September 2019
• Source: Scandinavia Pharma
• Contact: Javier Castillo, Dr
• Phone: +571-6461700
• Email: jcastill[@]scandinavia.com.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Colombia	Scandinavia Pharma	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Scandinavia Pharma

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of risk factors for adverse events associated to consumption of NSAIDs	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.	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	Demographic analysis	Characterization of patients	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	List of drugs used (by the patient) for treatment of osteoarthritis (OA)	List of drugs used (by the patient) for treatment of osteoarthritis (OA), including time of use and posology.	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	Evaluation of the current state of the disease according to functional limitation and pain	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.	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	Adverse Events related with the treatments	Evaluation of Adverse events associated with the treatment (s)	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