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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Abel Pereira, investigator | ABC School Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABC School of Medicine | São Paulo | 09060-650 | Brazil |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D013180 | Sprains and Strains |
| D052256 | Tendinopathy |
| D063806 | Myalgia |
| D003288 | Contusions |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D007660 | Ketoprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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 |
|
| five days |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D009468 | Neuromuscular Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D014949 | Wounds, Nonpenetrating |