NCT05013567

Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain

Randomized, Double-Blind, Parallel, Phase III Superiority Clinical Trial to Evaluate the Efficacy and Safety of Ibuprofen Gel Compared With Placebo in the Treatment of Acute Musculoskeletal Pain

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Brainfarma Industria Química e Farmacêutica S/A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.

Detailed description

This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves. It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis. The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.

Conditions

• Musculoskeletal Pain
• Acute Pain
• Stretch
• Sprains

Interventions

Type	Name	Description
DRUG	Ibuprofen gel	Ibuprofen gel 5% topically four times a day
OTHER	Placebo	Placebo gel topically four times a day

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2021-08-19
• Last updated: 2022-03-21