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Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal

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ClinicalTrials.gov Identifier: NCT03584308
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Brief Summary:
A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.

Condition or disease Intervention/treatment Phase
Papilloma Viral Infection Papillomavirus Infections Esophageal Viral Wart Esophageal Verrucous Carcinoma Dietary Supplement: Viusid® Dietary Supplement: Glizigen® Dietary Supplement: Viusid Placebo Dietary Supplement: Glizigen Placebo Phase 2

Detailed Description:

Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm.

However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random assignment, through a list obtained by computer. Patients will be randomized in the consultation of the upper digestive tract, once the anatomopathological result with the presence of coilocytes is received, and they meet the established selection criteria.
Masking: Double (Participant, Investigator)
Masking Description: A double blind. To achieve the masking of the research product, these have been labeled by a computerized randomized balanced list, which will be in the possession of the promoter and the study Biostatistician. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : December 15, 2018

Arm Intervention/treatment
Experimental: Viusid® + Glizigen®
The experimental arm will receive nutritional supplements Viusid + Glizigen
Dietary Supplement: Viusid®
The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner.

Dietary Supplement: Glizigen®
The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.

Placebo Comparator: Placebo
The control group will receive a placebo of both (Viusid and Glizigen).
Dietary Supplement: Viusid Placebo
The placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner .

Dietary Supplement: Glizigen Placebo
The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.




Primary Outcome Measures :
  1. Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample [ Time Frame: 3 months ]
    Absence of coilocytes / papilloma in the paraffin sample

  2. Clinical negativization of the virus in esophageal mucosal tissue sample [ Time Frame: 3 months ]
    Negativization of the virus in fresh sample of the mucosa in the PCR study


Secondary Outcome Measures :
  1. Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Acanthosis: Yes or No

  2. Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Papillary hyperplasia lamina propria: Yes or no

  3. Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Hyperplasia of the basal layer of the epithelium: Yes or No

  4. Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Dyskeratosis: Yes or No

  5. Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Dysplasia: Yes (Low Degree or High Degree) or No

  6. Toxicity due to the Treatment administered [ Time Frame: 3 months ]
    It will be determined through the reporting of adverse events that are presented to the research product



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older adults between 18 and 65 years of both sexes.
  • Patients residing in the provinces of Havana, Artemisa and Mayabeque.
  • Voluntariness of the patient to participate in the study. Informed and written consent.
  • Women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Contraindication to the performance of upper digestive endoscopy.
  • Psychiatric conditions that do not favor the administration of treatment and follow-up.
  • History of hypersensitivity to another similar product.
  • Severe acute allergic states.
  • Patients with concomitant diagnosis of esophageal tumor or other causes of infectious esophagitis.
  • Present an associated chronic illness in the decompensation phase (heart disease, diabetes, hypertension, renal failure, AIDSl).
  • Patients who are receiving another product under investigation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584308


Locations
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Cuba
Gastroenterology Institute
Vedado, La Habana, Cuba, 10600
Sponsors and Collaborators
Catalysis SL

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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03584308     History of Changes
Other Study ID Numbers: VIUSID-GLIZ-PAPILOMA
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catalysis SL:
Papillomavirus
Viusid
Glizigen
Papilloma virus Esophageal
Antioxidant

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Carcinoma, Verrucous
Papilloma
Virus Diseases
Papillomavirus Infections
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
DNA Virus Infections
Tumor Virus Infections