Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel
Information source: Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Muscular Atrophy; Sprains; Tendonitis
Intervention: Ibuprofen (Drug); Profenid (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Laboratório Teuto Brasileiro S/A Official(s) and/or principal investigator(s): Abel Pereira, investigator, Principal Investigator, Affiliation: ABC School Medicine
Overall contact: Abel Pereira, researcher, Phone: 11 55 4993-5459, Email: abelpsjr@terra.com.br
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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. "
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
Minimum age: 12 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Abel Pereira, researcher, Phone: 11 55 4993-5459, Email: abelpsjr@terra.com.br
ABC School of Medicine, São Paulo 09060-650, Brazil; Not yet recruiting Gilberto Brandão, investigator, Phone: (11) 3825-5666, Email: gilbertobrandao@hotmail.com
Additional Information
Starting date: June 2011
Last updated: June 14, 2011
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