Muscular Atrophy, Sprains, Tendonitis
Conditions
Keywords
Ibuprofen, muscle pain, sprains, contusions, tendonitis
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.
Interventions
DRUGIbuprofen
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
DRUGProfenid
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
Sponsors
Laboratório Teuto Brasileiro S/A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
Primary ContactAbel Pereira, researcher
Backup ContactThabata Veiga, coordinator
Outcome results
None listed