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

Osteoarthritis Clinical Trial

— APS003/2020  

Official title:

National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637529
• Other study ID #: APS003/2020
• Status: Completed
• Phase: Phase 2
• Start date: August 5, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Apsen Farmaceutica S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß - hCG urine test;

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuvix®
• Ibuvix® - ibuprofen
Ibuvix® + placebo of S(+) - Ibuprofen

Locations

Country	Name	City	State
Brazil	Apsen Farmacêutica S.A.	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Apsen Farmaceutica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)		Baseline (day 0) and Week 4 (day 28)
Secondary	Patient Global Impression of Improvement-I (PGI-I)		Week 4 (day 28)
Secondary	Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability		From Baseline (day 0) to Week 4 (day 28)