Clinical trial NCT01373697: Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Muscular Atrophy
Sprains
Tendonitis
Keywords: Ibuprofen
muscle pain
sprains
contusions
tendonitis
Lead sponsor: Laboratório Teuto Brasileiro S/A
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 144
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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. "
timeFrame: five days
Secondary outcomes:
measure: 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. "
timeFrame: five days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ABC School of Medicine
Study officials:
affiliation: ABC School Medicine
name: Abel Pereira, investigator
role: PRINCIPAL_INVESTIGATOR
References: