OsteoarthritisORCANCT04099459
ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
An observational study of Osteoarthritis, run by Scandinavia Pharma at 1 site in Colombia.
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). Read more about this study
- Who is it for?
- Ages 38 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 1,250 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jun 2019to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Scandinavia Pharma
Bogotá, 110111
Javier Castillo, Dr, +571-6461700, jcastill@scandinavia.com.co
About this study
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).
Read the 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.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Characterization of patients
Measured: 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)
List of drugs used (by the patient) for treatment of osteoarthritis (OA), including time of use and posology.
Measured: 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
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.
Measured: 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
Evaluation of Adverse events associated with the treatment (s)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start10 Jun 2019
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scandinavia Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Castillo, Dr, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099459
- Sponsor's protocol ID
- ORCA
- Acronym
- ORCA
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
- ClinicalTrials.gov ID
- NCT04099459
- Acronym / sponsor ID
- ORCA / ORCA
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Scandinavia PharmaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of risk factors for adverse events associated to consumption of NSAIDs
Time frame: 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.
4 secondary outcomes
Demographic analysis
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Comparative Effect of Dual Task Training and Rhythmic Stabilization in Knee Osteoarthritis Patients
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Castillo, Dr study director
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Scandinavia Pharma at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Castillo, Dr (+571-6461700, jcastill@scandinavia.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of risk factors for adverse events associated to consumption of NSAIDs (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.