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

Primary Purpose

Muscular Atrophy, Sprains, Tendonitis

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Ibuprofen
Profenid
Sponsored by
Laboratório Teuto Brasileiro S/A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Atrophy focused on measuring Ibuprofen, muscle pain, sprains, contusions, tendonitis

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ABC School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Profenid

Ibuprofen

Arm Description

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

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

Outcomes

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. "
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. "
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.

Full Information

First Posted
March 22, 2011
Last Updated
June 14, 2011
Sponsor
Laboratório Teuto Brasileiro S/A
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1. Study Identification

Unique Protocol Identification Number
NCT01373697
Brief Title
Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratório Teuto Brasileiro S/A

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy, Sprains, Tendonitis
Keywords
Ibuprofen, muscle pain, sprains, contusions, tendonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Profenid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Profenid
Intervention Description
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
Primary Outcome Measure Information:
Title
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. "
Description
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.
Time Frame
five days
Secondary Outcome Measure Information:
Title
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. "
Description
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.
Time Frame
five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abel Pereira, researcher
Phone
11 55 4993-5459
Email
abelpsjr@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Thabata Veiga, coordinator
Phone
11 55 4993-5459
Email
thabataveiga.pesquisa@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abel Pereira, investigator
Organizational Affiliation
ABC School Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABC School of Medicine
City
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilberto Brandão, investigator
Phone
(11) 3825-5666
Email
gilbertobrandao@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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