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

Laboratório Teuto Brasileiro

Status and phase: Unknown; Phase 3

Conditions: Tendonitis; Sprains; Muscular Atrophy

Treatments: Drug: Profenid; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01373697

TEU-IBU- 01-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

Profenid

Active Comparator group

Description:

Apply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal

Treatment:

Drug: Profenid

Ibuprofen

Active Comparator group

Description:

Apply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal

Treatment:

Drug: Ibuprofen