Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel

Clinical Multicenter, Phase III, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ibuprofen 50mg/g Gel in the Treatment of Patients With Muscle Pain, Joint, or Pain Caused by Sprains, Contusions, Tendinitis, or Myofascial Compared to Profenid ® 25mg/g. Gel

The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to Profenid 25mg/g gel.

The main objective of this study is to evaluate the efficacy of ibuprofen 50 mg/g gel in the treatment of patients with muscle, joint pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid 25mg/g gel.

Inclusion Criteria:

• Patients of both sexes, of any race, aged 12 years;
• Ability to read, understand and sign the Informed Consent in the case of minors monitoring and consent of a parent;
• Complaint of clinical muscle pain, joint pain caused by sprains, contusions, tendonitis, or myofascial;
• Score more than 4 VAS symptom reviewed: Pain;
• Patients able to understand and follow the protocol of the trial.
• Patients with or without ligament injury ligament injury partial and incomplete

Exclusion Criteria:

• Known hypersensitivity to components of the formula, both the medication and the comparative test;
• Hypersensitivity to acetylsalicylic acid;
• Hypersensitivity to ketoprofen, ibuprofen or other anti-inflammatory steroid;
• Hypersensitivity to acetaminophen;
• Skin changes in the pathological site of application, such as eczema or acne, or infected skin or wound;
• Pregnant or lactating women.
• Patients who require surgery or immobilization;
• Patients with fractures or ligament rupture;
• Patients taking anticoagulants;
• Patients with decompensated concomitant systemic diseases, such as diabetes, congenital or acquired blood disorders, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders;
• Use of NSAIDs, corticosteroids or venotherapics, threads or any other form of administration;
• History of alcoholism or substance abuse;
• Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.