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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

Page last updated: August 23, 2015

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