A Phase 2 interventional study of Viusid® and Glizigen® in Papilloma Viral Infection, Papillomavirus Infections and Esophageal Viral Wart, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by Catalysis SL · Phase 2, Interventional, and Treatment
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.
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's enrollment of 110 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental arm will receive nutritional supplements Viusid + Glizigen
Dietary Supplement: Viusid® · Dietary Supplement: Glizigen®
The control group will receive a placebo of both (Viusid and Glizigen).
Dietary Supplement: Viusid Placebo · Dietary Supplement: Glizigen Placebo
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.
The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
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 .
The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample
Absence of coilocytes / papilloma in the paraffin sample
Time frame: 3 months
Clinical negativization of the virus in esophageal mucosal tissue sample
Negativization of the virus in fresh sample of the mucosa in the PCR study
Time frame: 3 months
Evaluation of esophageal pathology
Acanthosis: Yes or No
Time frame: 3 months
Evaluation of esophageal pathology
Papillary hyperplasia lamina propria: Yes or no
Time frame: 3 months
Evaluation of esophageal pathology
Hyperplasia of the basal layer of the epithelium: Yes or No
Time frame: 3 months
Evaluation of esophageal pathology
Dyskeratosis: Yes or No
Time frame: 3 months
Evaluation of esophageal pathology
Dysplasia: Yes (Low Degree or High Degree) or No
Time frame: 3 months
Toxicity due to the Treatment administered
It will be determined through the reporting of adverse events that are presented to the research product
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Viusid · Glycyrrhizic Acid