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

NCT01373697 | Unknown Phase 3 DMC

• 1 other identifier: TEU-IBU- 01-10
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscular Atrophy; Sprains; Tendonitis

Keywords

Ibuprofen; muscle pain; sprains; contusions; tendonitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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. "

  five days

Study Arms (2)

Profenid

ACTIVE COMPARATOR

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

Ibuprofen

ACTIVE COMPARATOR

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

Interventions

Ibuprofen DRUG

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

Ibuprofen

Profenid DRUG

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

Profenid

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratório Teuto Brasileiro S/A: lead

Study Sites (1)

ABC School of Medicine

São Paulo, 09060-650, Brazil

Location

MeSH Terms

Conditions

Muscular Atrophy; Sprains and Strains; Tendinopathy; Myalgia; Contusions

Interventions

Ibuprofen; Ketoprofen

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Neuromuscular Diseases; Musculoskeletal Pain; Pain; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Abel Pereira, investigator

  ABC School Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abel Pereira, researcher

CONTACT

11 55 4993-5459; abelpsjr@terra.com.br

Thabata Veiga, coordinator

CONTACT

11 55 4993-5459; thabataveiga.pesquisa@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: June 15, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

BR (1)