Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel

Last updated: June 14, 2011
Sponsor: Laboratório Teuto Brasileiro S/A
Overall Status: Trial Status Unknown

Phase

3

Condition

Sprains

Muscular Dystrophy

Myasthenia Gravis (Chronic Weakness)

Treatment

N/A

Clinical Study ID

NCT01373697
TEU-IBU- 01-10
  • Ages 12-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 minorsmonitoring 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

Exclusion Criteria:

  • Known hypersensitivity to components of the formula, both the medication and thecomparative 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, orinfected 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 ofadministration;

  • History of alcoholism or substance abuse;

  • Conditions in the opinion of the investigator make the patient unsuitable toparticipate in the study.

Study Design

Total Participants: 144
Study Start date:
June 01, 2011
Estimated Completion Date:
August 31, 2011

Study 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.

Connect with a study center

  • ABC School of Medicine

    São Paulo, 09060-650
    Brazil

    Site Not Available

  • ABC School of Medicine

    São Paulo, 09060-650
    Brazil

    Site Not Available

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