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Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
Sponsor: Healthgen Biotechnology Corp.
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.
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2024-12-19
Completion Date
2025-05-15
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
Recombinant Human Chymotrypsin(OsrhCT) 4000U
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder
Placebo for Recombinant Human Chymotrypsin(OsrhCT)
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/vial, freeze-dried powder
Dimethicone emulsion 4ml
Dimethicone emulsion,produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle.
Locations (5)
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Chinese PLA Central Theatre General Hospital
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
the Central Hospital of Wuhan
Wuhan, Hubei, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China