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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: |
RPCEC00000095 |
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Date of registration:
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21/04/2010 |
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Primary sponsor: |
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Public title:
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Mebendazole compared with secnidazole-adult giardiasis-Phase III
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Scientific title:
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Efficacy and safety of mebendazole compared with secnidazole in the treatment of adult giardiasis: a randomised clinical trial |
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Date of first enrolment:
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04/05/2006 |
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Target sample size:
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110 |
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Recruitment status: |
Closed |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000095-En |
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Study type:
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Interventional |
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Study design:
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Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel 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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Pedro
Almirall Carbonell |
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Address:
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Calle D entre Zapata y 29 (Vedado) Plaza.
10400
Havana city
Cuba |
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Telephone:
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53 7 8326550 |
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Email:
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almicar@infomed.sld.cu |
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Affiliation:
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Faculty of Medical Sciences "Comandante Manuel Fajardo" |
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Name:
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Pedro
Almirall Carbonell |
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Address:
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Calle D entre Zapata y 29 (Vedado) Plaza.
10400
Havana city
Cuba |
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Telephone:
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53 7 8326550 |
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Email:
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almicar@infomed.sld.cu |
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Affiliation:
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Faculty of Medical Sciences "Comandante Manuel Fajardo" |
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Key inclusion & exclusion criteria
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Inclusion criteria: Informed-consent form signed. Patients with 18 years and older.
Exclusion criteria: Patients who had previously received any antiparasitic drug within 1 month before entering the study. Have known about any hypersensitivity to any of the drugs in use. Have any immunodeficiency disease. Have any hepatic disease. Have any renal disease. Have any cardiovascular disease. Have any haematological disease. Have used other drugs joined to the drugs in use. Women were pregnant or lactation.
Age minimum:
18 years
Age maximum:
None
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Giardiasis
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Intervention(s)
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Group I (Experimental): Mebendazole 200 mg by oral route three times during three days, (64 patients). Group II (Control): Secnidazole 2g by oral route in a single dose, a single day, (62 patients).
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Primary Outcome(s)
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Parasitological answer (Cured: If no Giardia cysts or trophozoites be found in any of the three post-treatment faecal simples, Not cured: Other case (microscopical examination as direct wet mount and Ritchie concentration. Measuring time: 3, 5 and 7 days after treatment completion. Clinical answer (Without clinical manifestations, with a relieve of the clinical manifestations, with the same clinical manifestations). Measuring time: 12 days after treatment completion.
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Secondary Outcome(s)
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Adverse Events (description of the events). Measuring time: 3 days after treatment completion. Intensity of AE (Slight, moderate or severe, taking into account the grade of disfunction produced by the event). Measuring time: 3 days after treatment completion.
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Source(s) of Monetary Support
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Central Military Hospital "Carlos J. Finlay"
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