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
Overview
- Phase
- Phase 3
- Sponsor
- Laboratório Teuto Brasileiro S/A
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- 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. "
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
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
Intervention: Profenid (Drug)
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
Intervention: Ibuprofen (Drug)
Outcomes
Primary Outcomes
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. "
Time Frame: 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 Outcomes
- 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)