Trial | NCT01373697  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ibuprofen ...

  • Study Participants

    144
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.
Study Started
Jun 30
2011
Primary Completion
Aug 31
2011
Anticipated
Study Completion
Aug 31
2011
Anticipated
Last Update
Jun 15
2011
Estimate

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

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

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

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.
No Results Posted