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

NCT04637529 | Completed Phase 2

• 1 other identifier: APS003/2020
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Nonsteroidal anti-inflammatory; Pain; Ibuprofen; Inflammation; Anti-inflammatory; Pain control; Osteoarthritis; Pain relief; Enzyme Inhibitors

Outcome Measures

Primary Outcomes (1)

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

  Baseline (day 0) and Week 4 (day 28)

Secondary Outcomes (2)

• 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)

Study Arms (2)

S (+) - Ibuprofen

EXPERIMENTAL

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

Drug: S (+) - Ibuprofen

Ibuvix® - ibuprofen

ACTIVE COMPARATOR

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

Drug: Ibuvix® - ibuprofen

Interventions

S (+) - Ibuprofen DRUG

S (+) - Ibuprofen + placebo of Ibuvix®

S (+) - Ibuprofen

Ibuvix® - ibuprofen DRUG

Ibuvix® + placebo of S(+) - Ibuprofen

Ibuvix® - ibuprofen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (1)

Apsen Farmacêutica S.A.

São Paulo, 04753-001, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis; Pain; Inflammation; Agnosia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 19, 2020
• Study Start: August 5, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)