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

June 14, 2011 updated by: Laboratório Teuto Brasileiro S/A

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 09060-650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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
Active Comparator: 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
Drug: Ibuprofen
Apply the gel at the site of pain or injury, massaging gently to promote penetration of 8 in 8 hours for 5 days. Leave the gel on the premises at least 4 hours before removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. "
Time Frame: 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.
five days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. "
Time Frame: five days
To evaluate the tolerability 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 use a measure using Naranjo algorithm to determinate the causality of the events.
five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratório Teuto Brasileiro S/A

Investigators

  • Principal Investigator: Abel Pereira, investigator, ABC School Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEU-IBU- 01-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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