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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

March 22, 2011
June 14, 2011
June 2011
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01373697 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Muscular Atrophy
  • Sprains
  • Tendonitis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
144
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years to 65 Years
No
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
Brazil
 
NCT01373697
TEU-IBU- 01-10
Yes
PHC Pharma Consulting, Dagoberto Brandão
Laboratório Teuto Brasileiro S/A
Not Provided
Principal Investigator: Abel Pereira, investigator ABC School Medicine
Laboratório Teuto Brasileiro S/A
June 2011

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