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

Phase 3

• Conditions: Muscular Atrophy; Sprains; Tendonitis
• Interventions: Drug: Profenid; Drug: Ibuprofen

• Registration Number: NCT01373697
• Lead Sponsor: Laboratório Teuto Brasileiro S/A

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-03-22
• Status Verified: 2011-06
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-14
• Last Update Submitted: 2011-06-14
• Study First Posted: 2011-06-15
• Last Update Posted: 2011-06-15
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Profenid	Profenid	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
Ibuprofen	Ibuprofen	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

Primary Outcome Measures

Name	Time	Method
Clinical study evaluating 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. "	five days	To evaluate the efficacy of ibuprofen 50 mg / g gel in the treatment of patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared with Profenid® Gel 25mg / g, will be used two methods. 1. the visual analog scale (VAS)and 2. investigator's opinion to measure before and after treatment comparing the decrease of the symptoms. The study will have 144 patients to be included with any sex or race, minimum age 12 years.

Secondary Outcome Measures

Name	Time	Method
Clinical study evaluating the tolerability 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. "	five days	To evaluate the tolerability of ibuprofen 50 mg / g gel in the treatment of patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared with Profenid ® Gel 25mg / g will be use a measure using Naranjo algorithm to determinate the causality of the events.

Trial Locations

Locations (1)

ABC School of Medicine; 🇧🇷 São Paulo, Brazil