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

Muscular Atrophy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01373697
• Other study ID #: TEU-IBU- 01-10
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 22, 2011
• Last updated: June 14, 2011
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: June 2011
• Source: Laboratório Teuto Brasileiro S/A
• Contact: Abel Pereira, researcher
• Phone: 11 55 4993-5459
• Email: abelpsjr[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Muscular Atrophy
• Sprains
• Tendonitis

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	ABC School of Medicine	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratório Teuto Brasileiro S/A

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. "	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	Yes
Secondary	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. "	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	Yes