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Completed

NCT Number: NCT04637529

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

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.

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Key information

Conditions

Osteoarthritis Agnosia Arthritis Inflammation Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Apsen Farmacêutica S.A.

São Paulo, 04753-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

S (+) - Ibuprofen

Drug

S (+) - Ibuprofen + placebo of Ibuvix®

Ibuvix® - ibuprofen

Drug

Ibuvix® + placebo of S(+) - Ibuprofen

Primary outcomes

  1. Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)

    Time frame: Baseline (day 0) and Week 4 (day 28)

Secondary outcomes

  1. Patient Global Impression of Improvement-I (PGI-I)

    Time frame: Week 4 (day 28)

  2. 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)

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study 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

Acronym: APS003/2020

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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