Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain (APS003/2020)

Apsen Farmaceutica

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: S (+) - Ibuprofen; Drug: Ibuvix® - ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT04637529

APS003/2020

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.

Enrollment: 176 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to American College of Rheumatology (ACR) criteria.

Main Exclusion Criteria:

• Known hypersensitivity to the formula components used during the clinical trial;
• 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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176 participants in 2 patient groups

S (+) - Ibuprofen

Experimental group

Description:

S (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days.

Treatment:

Drug: S (+) - Ibuprofen

Ibuvix® - ibuprofen

Active Comparator group

Description:

Ibuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days.

Treatment:

Drug: Ibuvix® - ibuprofen