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

Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Papillomavirus Infections; Papilloma Viral Infection; Esophageal Viral Wart; Esophageal Verrucous Carcinoma
• Intervention / Treatment: Dietary supplement: Viusid®; Dietary supplement: Glizigen®; Dietary supplement: Viusid Placebo; Dietary supplement: Glizigen Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Cuba
  • La Habana
    • Vedado, La Habana, Cuba, 10600
      • Gastroenterology Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample	Absence of coilocytes / papilloma in the paraffin sample	3 months
Clinical negativization of the virus in esophageal mucosal tissue sample	Negativization of the virus in fresh sample of the mucosa in the PCR study	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of esophageal pathology	Acanthosis: Yes or No	3 months
Evaluation of esophageal pathology	Papillary hyperplasia lamina propria: Yes or no	3 months
Evaluation of esophageal pathology	Hyperplasia of the basal layer of the epithelium: Yes or No	3 months
Evaluation of esophageal pathology	Dyskeratosis: Yes or No	3 months
Evaluation of esophageal pathology	Dysplasia: Yes (Low Degree or High Degree) or No	3 months
Toxicity due to the Treatment administered	It will be determined through the reporting of adverse events that are presented to the research product	3 months

Collaborators and Investigators

• Sponsor: Catalysis SL

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Papillomavirus; Viusid; Glizigen; Papilloma virus Esophageal; Antioxidant
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Infections; Communicable Diseases; Virus Diseases; Papillomavirus Infections; Papilloma; Carcinoma, Verrucous
• Other Study ID Numbers: VIUSID-GLIZ-PAPILOMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No