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

Primary Purpose

Papilloma Viral Infection, Papillomavirus Infections, Esophageal Viral Wart

Status

Completed

Phase

Phase 2

Locations

Cuba

Study Type

Interventional

Intervention

Viusid®

Glizigen®

Viusid Placebo

Glizigen Placebo

About this trial

This is an interventional treatment trial for Papilloma Viral Infection focused on measuring Papillomavirus, Viusid, Glizigen, Papilloma virus Esophageal, Antioxidant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gastroenterology Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viusid® + Glizigen®

Placebo

Arm Description

The experimental arm will receive nutritional supplements Viusid + Glizigen

The control group will receive a placebo of both (Viusid and Glizigen).

Outcomes

Primary Outcome Measures

Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample

Absence of coilocytes / papilloma in the paraffin sample

Clinical negativization of the virus in esophageal mucosal tissue sample

Negativization of the virus in fresh sample of the mucosa in the PCR study

Secondary Outcome Measures

Evaluation of esophageal pathology

Acanthosis: Yes or No

Evaluation of esophageal pathology

Papillary hyperplasia lamina propria: Yes or no

Evaluation of esophageal pathology

Hyperplasia of the basal layer of the epithelium: Yes or No

Evaluation of esophageal pathology

Dyskeratosis: Yes or No

Evaluation of esophageal pathology

Dysplasia: Yes (Low Degree or High Degree) or No

Toxicity due to the Treatment administered

It will be determined through the reporting of adverse events that are presented to the research product

Full Information

NCT ID

NCT03584308

First Posted

June 28, 2018

Last Updated

May 21, 2019

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT03584308

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

October 15, 2015 (Actual)

Primary Completion Date

May 15, 2018 (Actual)

Study Completion Date

December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papilloma Viral Infection, Papillomavirus Infections, Esophageal Viral Wart, Esophageal Verrucous Carcinoma

Keywords

Papillomavirus, Viusid, Glizigen, Papilloma virus Esophageal, Antioxidant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Viusid® + Glizigen®

Arm Type

Experimental

Arm Description

The experimental arm will receive nutritional supplements Viusid + Glizigen

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The control group will receive a placebo of both (Viusid and Glizigen).

Intervention Type

Dietary Supplement

Intervention Name(s)

Viusid®

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Glizigen®

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Viusid Placebo

Intervention Description

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 .

Intervention Type

Dietary Supplement

Intervention Name(s)

Glizigen Placebo

Intervention Description

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 Measure Information:

Title

Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample

Description

Absence of coilocytes / papilloma in the paraffin sample

Time Frame

3 months

Title

Clinical negativization of the virus in esophageal mucosal tissue sample

Description

Negativization of the virus in fresh sample of the mucosa in the PCR study

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Evaluation of esophageal pathology

Description

Acanthosis: Yes or No

Time Frame

3 months

Title

Evaluation of esophageal pathology

Description

Papillary hyperplasia lamina propria: Yes or no

Time Frame

3 months

Title

Evaluation of esophageal pathology

Description

Hyperplasia of the basal layer of the epithelium: Yes or No

Time Frame

3 months

Title

Evaluation of esophageal pathology

Description

Dyskeratosis: Yes or No

Time Frame

3 months

Title

Evaluation of esophageal pathology

Description

Dysplasia: Yes (Low Degree or High Degree) or No

Time Frame

3 months

Title

Toxicity due to the Treatment administered

Description

It will be determined through the reporting of adverse events that are presented to the research product

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Gastroenterology Institute

City

Vedado

State/Province

La Habana

ZIP/Postal Code

10600

Country

Cuba

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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