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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Muscular Atrophy, Sprains, Tendonitis

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Profenid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Profenid<br>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 | Drug: Profenid<br>* 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<br>|
| Active Comparator: Ibuprofen<br>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 | Drug: Ibuprofen<br>* Apply the gel at the site of pain or injury, massaging gently to promote penetration of 8 in 8 hours for 5 days. Leave the gel on the premises at least 4 hours before removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.  | 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. | five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.  | 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. | five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ibuprofen, muscle pain, sprains, contusions, tendonitis