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ACTIVE NOT RECRUITING
NCT06722664
PHASE2

Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.

Sponsor: Healthgen Biotechnology Corp.

View on ClinicalTrials.gov

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

Interventions

DRUG

Recombinant Human Chymotrypsin(OsrhCT) 4000U

Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder

DRUG

Placebo for Recombinant Human Chymotrypsin(OsrhCT)

Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/vial, freeze-dried powder

DRUG

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