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

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: S (+) - Ibuprofen; Drug: Ibuvix® - ibuprofen

• Registration Number: NCT04637529
• Lead Sponsor: Apsen Farmaceutica S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Study Start: 2022-08-05
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)	Baseline (day 0) and Week 4 (day 28)

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement-I (PGI-I)	Week 4 (day 28)
Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability	From Baseline (day 0) to Week 4 (day 28)

Trial Locations

Locations (1)

Apsen Farmacêutica S.A.; 🇧🇷 São Paulo, Brazil