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

Catalysis SL

Status and phase: Completed; Phase 2

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

Treatments: Dietary Supplement: Glizigen Placebo; Dietary Supplement: Viusid®; Dietary Supplement: Viusid Placebo; Dietary Supplement: Glizigen®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03584308

VIUSID-GLIZ-PAPILOMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Viusid® + Glizigen®

Experimental group

Description:

The experimental arm will receive nutritional supplements Viusid + Glizigen

Treatment:

Dietary Supplement: Viusid®

Dietary Supplement: Glizigen®

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Viusid Placebo

Dietary Supplement: Glizigen Placebo