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

Papillomavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584308
• Other study ID #: VIUSID-GLIZ-PAPILOMA
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2015
• Est. completion date: December 15, 2018

Study information

• Verified date: June 2018
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Esophageal Verrucous Carcinoma
• Esophageal Viral Wart
• Infection
• Papilloma
• Papilloma Viral Infection
• Papillomavirus Infections
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Cuba	Gastroenterology Institute	Vedado	La Habana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample	Absence of coilocytes / papilloma in the paraffin sample	3 months
Primary	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	Evaluation of esophageal pathology	Acanthosis: Yes or No	3 months
Secondary	Evaluation of esophageal pathology	Papillary hyperplasia lamina propria: Yes or no	3 months
Secondary	Evaluation of esophageal pathology	Hyperplasia of the basal layer of the epithelium: Yes or No	3 months
Secondary	Evaluation of esophageal pathology	Dyskeratosis: Yes or No	3 months
Secondary	Evaluation of esophageal pathology	Dysplasia: Yes (Low Degree or High Degree) or No	3 months
Secondary	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