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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 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. "
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: 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
干预措施: Ibuprofen (Drug)
结局指标
主要结局
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. "
时间窗: 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.
次要结局
- 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)