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

July 13, 2023 updated by: Apsen Farmaceutica S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04753-001
        • Apsen Farmacêutica S.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S (+) - Ibuprofen
S (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days.
Drug: S (+) - Ibuprofen
S (+) - Ibuprofen + placebo of Ibuvix®
Active Comparator: Ibuvix® - ibuprofen
Ibuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days.
Drug: Ibuvix® - ibuprofen
Ibuvix® + placebo of S(+) - Ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)
Time Frame: Baseline (day 0) and Week 4 (day 28)
Baseline (day 0) and Week 4 (day 28)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apsen Farmaceutica S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS003/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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