Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
brief summary
Study was designed to evaluate efficacy of OsrhCT and Dimethicone emulsion before upper endoscopy on visibility of gastric mucosa. A total of 336 subjects (both male and female) are expected to be enrolled in this trial.
detailed description
This is a monocentric, double-blind, randomized study involving 336 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of three arms, with OsrhCT 4000U+ Dimethicone emulsion 4ml , with OsrhCT 8000U+ Dimethicone emulsion 4ml , and with placebo for OsrhCT+ Dimethicone emulsion 4ml. During the examination, each photograph was individually taken in 5 defined areas. The first 30 cases were collected to establish standards and method validation. The visibility score was given by the sum of the score 1-4 from 5 defined localities evaluated by a blinded endoscopist and subsequently by two or three blinded endoscopists. Other parameters monitored were examination time and a semiquantitative evaluation of residual gastric fluid.
official title
A Phase 2 , Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Using Premedication With OsrhCT and Dimethicone Emulsion During Upper Gastrointestinal Endoscopy Examination.