Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain
NCT ID: NCT04637529
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2022-08-05
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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S (+) - Ibuprofen
S (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days.
S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuvix®
Ibuvix® - ibuprofen
Ibuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days.
Ibuvix® - ibuprofen
Ibuvix® + placebo of S(+) - Ibuprofen
Interventions
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S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuvix®
Ibuvix® - ibuprofen
Ibuvix® + placebo of S(+) - Ibuprofen
Eligibility Criteria
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Inclusion Criteria
* Patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to American College of Rheumatology (ACR) criteria.
Exclusion Criteria
* Previous history of alcohol or drugs abuse diagnosed by DSM-V;
* Current or previous history (less than 12 months) of smoking;
* Have clinically relevant abnormal laboratory results according to medical evaluation;
* Women who are pregnant, lactating, or positive for β - hCG urine test;
18 Years
75 Years
ALL
No
Sponsors
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Apsen Farmaceutica S.A.
INDUSTRY
Responsible Party
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Locations
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Apsen Farmacêutica S.A.
São Paulo, , Brazil
Countries
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Other Identifiers
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APS003/2020
Identifier Type: -
Identifier Source: org_study_id
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