Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Viusid® + Glizigen®
The experimental arm will receive nutritional supplements Viusid + Glizigen
干预措施: Viusid® (Dietary Supplement)
Viusid® + Glizigen®
The experimental arm will receive nutritional supplements Viusid + Glizigen
干预措施: Glizigen® (Dietary Supplement)
Placebo
The control group will receive a placebo of both (Viusid and Glizigen).
干预措施: Viusid Placebo (Dietary Supplement)
Placebo
The control group will receive a placebo of both (Viusid and Glizigen).
干预措施: Glizigen Placebo (Dietary Supplement)
结局指标
主要结局
Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample
时间窗: 3 months
Absence of coilocytes / papilloma in the paraffin sample
Clinical negativization of the virus in esophageal mucosal tissue sample
时间窗: 3 months
Negativization of the virus in fresh sample of the mucosa in the PCR study
次要结局
- Toxicity due to the Treatment administered(3 months)
- Evaluation of esophageal pathology(3 months)