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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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27 May 2013 |
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Main ID: |
RPCEC00000038 |
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Date of registration:
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20/12/2010 |
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Primary sponsor: |
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Public title:
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Dynamic-I
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Scientific title:
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Intramuscular application of a new freeze-dried formulation of albumin-free recombinant human alpha-2b interferon in Acuminate Condyloma patients. |
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Date of first enrolment:
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22/04/2003 |
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Target sample size:
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30 |
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Recruitment status: |
Closed |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000038-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: Uncontrolled 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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Idrian
Garcia Garcia |
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Address:
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134 street, between 23 and 25 street. Cubanacan, Playa
6162
Havana City
Cuba |
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Telephone:
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(53-7)- 2087379 |
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Email:
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idrian.garcia@cigb.edu.cu |
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Affiliation:
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Biological Researches Center, Clinical Trials Division |
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Name:
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Idrian
Garcia Garcia |
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Address:
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134 street, between 23 and 25 street. Cubanacan, Playa
6162
Havana City
Cuba |
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Telephone:
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(53-7)- 2087379 |
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Email:
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idrian.garcia@cigb.edu.cu |
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Affiliation:
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Biological Researches Center, Clinical Trials Division |
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Key inclusion & exclusion criteria
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Inclusion criteria: Clinical and histological diagnosis positive to Acuminate Condyloma by papilloma virus. Patients of both sexes with Acuminate Condyloma lesions in external genitals, perianal region, and inner thighs. Patients aged 18 to 60. No topical or systemic treatment with IFN or any other antiviral drug one month before inclusion in the study. Reproductive-age women using any non-hormonal contraceptive. Patient’s consent in writing to participate in the study.
Exclusion criteria: Other sexually transmitted diseases (syphilis, infectious urethritis, AIDS). Antiviral or immunosuppressor (corticosteroid, cytostatic) therapy three months before commencing INF treatment. Severe systemic and chronic diseases affecting the patient’s general condition and modifying therapeutic response, including malignant neoplasias and immunodeficiency. Lesion sepsis demanding systemic antibiotic treatment. Pregnancy or breastfeeding. Patients with history of hypersensitivity to alpha INF or any formulation component.
Age minimum:
18 years
Age maximum:
60 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acuminate Condyloma
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Intervention(s)
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Group I. One daily intramuscular application of 10x106 UI of the product under study for 2 consecutive days. Group II. One daily intramuscular application of 5x106 UI of the product under study for 4 consecutive days. Group III. One daily intramuscular application of 3x106 UI of the product under study for 7 consecutive days. The three groups will thus receive practically the same weekly dosage of 20x106 UI.
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Primary Outcome(s)
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Beta-2 microglobulin level, measuring time: before and after treatment. 2.5 oligoadenylate synthetase level, measuring time: before and after treatment.
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Secondary Outcome(s)
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Size of lesions (greater and lesser diameters), measuring time: before and after treatment. Number of lesions, measuring time: before and after treatment. Need for other conventional treatments, measuring time: before and after treatment.
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Secondary ID(s)
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IG/IAI/PD/0301
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Source(s) of Monetary Support
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Ministry of Public Health, CUBA
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