Eligibility Module

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Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module

Ignite Creation Date: 2025-12-24 @ 1:31 PM
Ignite Modification Date: 2025-12-24 @ 1:31 PM
NCT ID: NCT01226095
Eligibility Criteria: Inclusion Criteria: * Patients seeking treatment for osteoarthritis and there are clinical or radiological evidence of the disease, * Male or female, age ≥ 18 * Designated to treatment with Ibuprofen in a sustained release form (Brufen Retard) according to the best criterion of the physician and if he decides to treat the patient according to labeled indication and dose for 4 weeks. * Patients who have given their written informed consent to participate in the study * Patients who are currently taking non steroidal anti inflammatory drugs (NSAIDs), should complete an initial washout phase 10 days depending on the half life of the drug taken Exclusion Criteria: * Contraindications as described in company core data sheet (CCDS) and specifically * Patients with active peptic ulcer * Patients who have presented reactions of hypersensitivity (asthma , rhinitis or urticaria ) with ibuprofen or other anti-inflammatory non steroids * Patients with active cardiovascular disease and those taking aspirin/warfarin for prophylaxis for myocardial infarction (MI) or stroke * Patients with moderate to severe renal diseases * Patients with moderate to severe hepatic disease * Patients with Crohn's disease * Patients included currently in another study * Women of childbearing potential must not be pregnant * Any patients the investigators consider ineligible for this study
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT01226095
Study Brief:
Protocol Section: NCT01226095