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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03584308
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE October 15, 2015
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample [ Time Frame: 3 months ]
    Absence of coilocytes / papilloma in the paraffin sample
  • Clinical negativization of the virus in esophageal mucosal tissue sample [ Time Frame: 3 months ]
    Negativization of the virus in fresh sample of the mucosa in the PCR study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Acanthosis: Yes or No
  • Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Papillary hyperplasia lamina propria: Yes or no
  • Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Hyperplasia of the basal layer of the epithelium: Yes or No
  • Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Dyskeratosis: Yes or No
  • Evaluation of esophageal pathology [ Time Frame: 3 months ]
    Dysplasia: Yes (Low Degree or High Degree) or No
  • Toxicity due to the Treatment administered [ Time Frame: 3 months ]
    It will be determined through the reporting of adverse events that are presented to the research product
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal
Official Title  ICMJE Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Papilloma Viral Infection
  • Papillomavirus Infections
  • Esophageal Viral Wart
  • Esophageal Verrucous Carcinoma
Intervention  ICMJE
  • 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.
  • 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.
  • 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 .
  • 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.
Study Arms  ICMJE
  • Experimental: Viusid® + Glizigen®
    The experimental arm will receive nutritional supplements Viusid + Glizigen
    Interventions:
    • Dietary Supplement: Viusid®
    • Dietary Supplement: Glizigen®
  • Placebo Comparator: Placebo
    The control group will receive a placebo of both (Viusid and Glizigen).
    Interventions:
    • Dietary Supplement: Viusid Placebo
    • Dietary Supplement: Glizigen Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584308
Other Study ID Numbers  ICMJE VIUSID-GLIZ-PAPILOMA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Catalysis SL
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Catalysis SL
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP