Papillomavirus Infections Clinical Trial
Official title:
Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial
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.
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