Muscular Atrophy | Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel
Muscular Atrophy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:IbuprofenApply 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
Drug:ProfenidApply 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ProfenidApply 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
IbuprofenApply 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
Start Date: June 2011
Completed Date: August 2011
Phase: Phase 3
Primary Outcome: 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. "
Secondary Outcome: 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. "
Study sponsors, principal investigator, and references
Principal Investigator: Abel Pereira, investigator
Lead Sponsor: Laboratório Teuto Brasileiro S/A