Study Of Effectiveness Of The Use Of Pancreatic Enzyme: Norzyme® -(Made In The Laboratory Pancrealipase Bergamo) Inpatients With Pancreatic Insufficiency In Use Substituteenzymatic When Compared To Product Creon®
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Balance of fat in feces.
研究概览
简要总结
Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay Farma Ltda.
详细描述
Phase III clinical trial systematic sampling, double-blind, randomized, crossed that evaluates the comparative efficacy of a formulation containing enzyme pancreas in 16 patients with pancreatic insufficiency exogenous of any cause. The study will be conducted with the inclusion of 16 adult patients, both sexes, regardless of color or social class, aged 14 to 65 years, clinically diagnosed as having pancreatic insufficiency exocrine any etiology (cystic fibrosis, cancer, pancreatectomy, Surgery by trauma). The Research Subjects will be recruited with the help of medical coinvestigador specialist Dr. Francisco Callejas Neto, who will offer their clinic patients to participate in the study. If there is interest from same, all are invited to attend the Clinic for total LAL clarification about the study of drug action, benefits, possible risks, compensation, study period, and finally understanding reading and signing together with the investigator of the Term of Consent.
The research subjects will have complete freedom to lead to the Informed Consent house, where they can review all items easy. After informed and the consent form and signed informed, patients will be examined by the researcher LAL Clinic which will perform a physical examination in the same general and specific. Will rated their personal background and reviewed the Inclusion and Excluded from the study.
Satisfying the criteria for inclusion in the study subjects are approved to participate in the study.
The 16 Subjects Research approved within the inclusion criteria and exclusion to participate in the study be included in the study as sequential by the number of their care. Later, the same will be inserted in randomization table, which was outlined in a randomized crossover for two drugs, the randomization scheme will be in the balanced cross 2 x 2. A design is said to be balanced if it satisfies the following conditions:
· Each medication is applied only once in each subject;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nclusion Criteria:
- •Research subjects aged between 14 and 65 years of both sexes;
- •Exogenous pancreatic insufficiency of any etiology;
- •Subjects who do not regularly use or pancreatic enzymes by orally;
- •Freely agree to sign the consent form and clarified before all the essential elements of the protocol be clarified before any procedure.
排除标准
- •Participation in any study or have ingested some experimental drug trial in the 3 months preceding the study.
- •Regular use of medication that interferes with the action of the drug test:
- •in the 4 weeks preceding the study or make use of any medications that interfere with drug test a week before the start the study.
- •Patients who take any kind of treatment for morbid obesity.
- •Cases of stomach reduction surgery.
- •Cases of surgical reduction of the intestine.
- •Present history of current abuse of alcohol or have drunk alcohol in the 48 hours prior to the study.
- •Have any condition which prevents him from participating in the study, for trial Principal Investigator.
研究组 & 干预措施
Norzyme®
干预措施: Pancreatic enzimes (Biological)
Creon®
干预措施: Creon ® (Device)
结局指标
主要结局
Balance of fat in feces.
时间窗: 06 weeks of treatment.
次要结局
- Prove the efficacy of pancreatic enzyme Norzyme ® through the activity of lipase in the formulation contained in the control of steatorrhea(06 weeks of treatment.)
研究者
Azidus Brasil
Principal Investigator Dr. Alexandre Frederico
Azidus Brasil
