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Active, not recruiting Phase 2

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

NCT06722664 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-12-19
Last updated
2025-04-29

Condition(s) studied

Gastric Mucosal Lesion

Investigational drug(s) / intervention(s)

Recombinant Human Chymotrypsin(OsrhCT) 4000UPlacebo for Recombinant Human Chymotrypsin(OsrhCT)Dimethicone emulsion 4ml →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients indicated for gastroscopy examination; 2. Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent; 3. Able to complete the research according to the requirements of the experimental plan; 4. Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug; 5. Aged 18-75 years (inclusive), male or female; Exclusion Criteria: 1. Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination; 2. Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc; 3. Subjects accessed not to stand sedation anesthesia or gastroscopy examination; 4. Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices; 5. Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery; 6. Abnormal laboratory values:: alanine aminotransferase (ALT)\>2 × ULN, aspartate aminotransferase (AST)\>2 × ULN, serum creatinine\>1.5 × ULN; 7. Female subjects who had unprotected sex within 14 days prior to screening; 8. Pregnant or breastfeeding women; 9. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months; 10. Any other conditions deemed unsuitable for the study by the investigator.

Primary outcome measure(s)

  • Total visibility score (TVS) evaluated by blinded endoscopists — Through study completion, an average of 3 months
    "Total visibility score"counted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum.

Trial sites (5)

FacilityCityRegionStatus
Beijing Friendship Hospital Beijing Beijing Municipality
Chinese PLA Central Theatre General Hospital Wuhan Hubei
Renmin Hospital of Wuhan University Wuhan Hubei
the Central Hospital of Wuhan Wuhan Hubei
Inner Mongolia Autonomous Region People's Hospital Hohhot Inner Mongolia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06722664 on ClinicalTrials.gov ↗ ← All trials in China