Clinical trial NCT03584308: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Papilloma Viral Infection
Papillomavirus Infections
Esophageal Viral Wart
Esophageal Verrucous Carcinoma
Keywords: Papillomavirus
Viusid
Glizigen
Papilloma virus Esophageal
Antioxidant
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-07-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample
timeFrame: 3 months
measure: Clinical negativization of the virus in esophageal mucosal tissue sample
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of esophageal pathology
timeFrame: 3 months
measure: Evaluation of esophageal pathology
timeFrame: 3 months
measure: Evaluation of esophageal pathology
timeFrame: 3 months
measure: Evaluation of esophageal pathology
timeFrame: 3 months
measure: Evaluation of esophageal pathology
timeFrame: 3 months
measure: Toxicity due to the Treatment administered
timeFrame: 3 months
Other outcomes:
Locations:
city: Vedado
country: Cuba
facility: Gastroenterology Institute
state: La Habana
Study officials:
References: