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

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratório Teuto Brasileiro S/A
• Treatments: Ibuprofen; Ketoprofen

Criteria

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.