ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
ORCA
1 other identifier
observational
1,250
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2019
CompletedFirst Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedSeptember 23, 2019
September 1, 2019
4.5 years
September 16, 2019
September 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
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
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
Eligibility Criteria
Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scandinavia Pharma
Bogotá, 110111, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javier Castillo, Dr
Medical Director
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 23, 2019
Study Start
June 10, 2019
Primary Completion
December 1, 2023
Study Completion
July 1, 2024
Last Updated
September 23, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share