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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RPCEC00000094 |
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Date of registration:
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01/03/2010 |
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Primary sponsor: |
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Public title:
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Lidoment - pain osteomioarticular - phase IV
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Scientific title:
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Lidoment, analgesic medicamental formulation for relief of the pain in the system osteomioarticular. |
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Date of first enrolment:
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30/06/2007 |
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Target sample size:
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200 |
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Recruitment status: |
Closed |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000094-En |
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Study type:
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Interventional |
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Study design:
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Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Malena
Zelada Pérez |
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Address:
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15th. street,corner at 18, Vedado.
10400
Havana City
Cuba |
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Telephone:
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5378356773 |
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Email:
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mzelada@infomed.sld.cu |
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Affiliation:
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Vedado Policlinical |
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Name:
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Malena
Zelada Pérez |
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Address:
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15th. street,corner at 18, Vedado.
10400
Havana City
Cuba |
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Telephone:
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5378356773 |
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Email:
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mzelada@infomed.sld.cu |
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Affiliation:
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Vedado Policlinical |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Patient of any age, sex and ethnic group that are remitted by the specialist in Anesthesiology, of the service of integral Rehabilitation of the Vedado Policlinical, payees of pains osteomioarticulars, which were remitted to their consultation to be valued and treaties. 2.The patients' consent to participate in the trial, included in the pattern of clinical history of the pain made for the same ones.
Exclusion criteria: a.Patients that presented some pathology like: sepsis in the affected area, oncological processes, bigger psychiatric dysfunctions and/or cerebral damage. b.The negative of the patients of participating in the investigation.
Age minimum:
18 years
Age maximum:
80 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Daily topical application of the analgesic gel, during 7 days. The formulation contains the mixture of Lidocaine 5% - 30 ml and Menthol 1%.
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Primary Outcome(s)
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Pain (analogue pain scale,0-10, 0 is no pain and 10 is the worst imaginable pain). Measurement time: Daily by the patient, 7 days after begining the treatment by the doctor.
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Secondary Outcome(s)
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Osteomioarticular system lesions (description of lesions). Measurement time: 7 days after begining the treatment.
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Source(s) of Monetary Support
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Ministry of Public Health, Cuba.
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