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

September 20, 2019 updated by: Scandinavia Pharma
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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scandinavia Pharma

Investigators

  • Study Director: Javier Castillo, Dr, Medical director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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