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

This study is not yet open for participant recruitment.

Verified June 2011 by Laboratório Teuto Brasileiro S/A

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2011

Last Updated Date

June 14, 2011

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01373697 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Muscular Atrophy
Sprains
Tendonitis

Intervention ^ICMJE

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
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

Study Arm (s)

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

Intervention: Drug: Profenid
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

Intervention: Drug: Ibuprofen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

144

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01373697

Other Study ID Numbers ^ICMJE

TEU-IBU- 01-10

Has Data Monitoring Committee

Yes

Responsible Party

PHC Pharma Consulting, Dagoberto Brandão

Study Sponsor ^ICMJE

Laboratório Teuto Brasileiro S/A

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Abel Pereira, investigator

ABC School Medicine

Information Provided By

Laboratório Teuto Brasileiro S/A

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top