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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Laboratório Teuto Brasileiro S/A.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01373697
First received: March 22, 2011
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Muscular Atrophy
Sprains
Tendonitis
Drug: Ibuprofen
Drug: Profenid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laboratório Teuto Brasileiro S/A:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 144
Study Start Date: June 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373697

Contacts
Contact: Abel Pereira, researcher 11 55 4993-5459 abelpsjr@terra.com.br
Contact: Thabata Veiga, coordinator 11 55 4993-5459 thabataveiga.pesquisa@yahoo.com.br

Locations
Brazil
ABC School of Medicine Not yet recruiting
São Paulo, Brazil, 09060-650
Contact: Gilberto Brandão, investigator    (11) 3825-5666    gilbertobrandao@hotmail.com   
Sponsors and Collaborators
Laboratório Teuto Brasileiro S/A
Investigators
Principal Investigator: Abel Pereira, investigator ABC School Medicine
  More Information

No publications provided

Responsible Party: PHC Pharma Consulting, Dagoberto Brandão
ClinicalTrials.gov Identifier: NCT01373697     History of Changes
Other Study ID Numbers: TEU-IBU- 01-10
Study First Received: March 22, 2011
Last Updated: June 14, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratório Teuto Brasileiro S/A:
Ibuprofen
muscle pain
sprains
contusions
tendonitis

Additional relevant MeSH terms:
Muscular Atrophy
Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Ibuprofen
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014