Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
NCT06722664 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 336
Last updated 2025-04-29
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.
Conditions
- Gastric Mucosal Lesion
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.
Sponsors & Collaborators
-
Beijing Friendship Hospital
collaborator OTHER -
Healthgen Biotechnology Corp.
lead INDUSTRY
Principal Investigators
-
Shutian Zhang, MD · Beijing Friendship Hospital
-
Fandong Meng, MD · Beijing Friendship Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-19
- Primary Completion
- 2025-05-15
- Completion
- 2025-05-15
Countries
- China
Study Locations
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