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

NCT ID: NCT03584308

Last Updated: 2019-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-15
• Study Completion Date: 2018-12-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Viusid® + Glizigen®

The experimental arm will receive nutritional supplements Viusid + Glizigen

Group Type: EXPERIMENTAL

Viusid®

Intervention Type: DIETARY_SUPPLEMENT

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®

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Viusid Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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 .

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterology Institute

Vedado, La Habana, Cuba

Countries

Cuba

Other Identifiers

VIUSID-GLIZ-PAPILOMA

Identifier Type: -

Identifier Source: org_study_id