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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099459
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Osteoarthritis

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.

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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Characterization of patients

  2. 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 ]
    List of drugs used (by the patient) for treatment of osteoarthritis (OA), including time of use and posology.

  3. 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 ]
    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.

  4. 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 ]
    Evaluation of Adverse events associated with the treatment (s)



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Ages Eligible for Study:   38 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099459


Contacts
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Contact: Javier Castillo, Dr +571-6461700 jcastill@scandinavia.com.co
Contact: Claudio Ferrari, Dr +571-6461700 cferrari@scandinavia.com.co

Locations
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Colombia
Scandinavia Pharma Recruiting
Bogotá, Colombia, 110111
Contact: Javier Castillo, Dr    +571-6461700    jcastill@scandinavia.com.co   
Sponsors and Collaborators
Scandinavia Pharma
Investigators
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Study Director: Javier Castillo, Dr Medical Director
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Responsible Party: Scandinavia Pharma
ClinicalTrials.gov Identifier: NCT04099459    
Other Study ID Numbers: ORCA
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases