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

Phase 2

Active, not recruiting

• Conditions: Gastric Mucosal Lesion
• Interventions: Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Drug: Dimethicone emulsion 4ml; Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT)

• Registration Number: NCT06722664
• Lead Sponsor: Healthgen Biotechnology Corp.

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.

Study Timeline

• Study First Submitted: 2024-11-26
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-09
• Study Start: 2024-12-19
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Human Chymotrypsin(OsrhCT) 8000U	Dimethicone emulsion 4ml	-
Placebo for Recombinant Human Chymotrypsin(OsrhCT)	Dimethicone emulsion 4ml	-
Recombinant Human Chymotrypsin(OsrhCT) 4000U	Recombinant Human Chymotrypsin(OsrhCT) 4000U	-
Recombinant Human Chymotrypsin(OsrhCT) 4000U	Placebo for Recombinant Human Chymotrypsin(OsrhCT)	-
Recombinant Human Chymotrypsin(OsrhCT) 4000U	Dimethicone emulsion 4ml	-
Recombinant Human Chymotrypsin(OsrhCT) 8000U	Recombinant Human Chymotrypsin(OsrhCT) 4000U	-
Placebo for Recombinant Human Chymotrypsin(OsrhCT)	Placebo for Recombinant Human Chymotrypsin(OsrhCT)	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach	Through study completion, an average of 3 months	Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus.
The amount of water flushed for satisfactory observation of the upper gastrointestinal tract	during diagnostic upper endoscopy, up to 1 hour	Amount of water used to allow an suitable visualization of gastric mucosa
Duration of endoscopy	during diagnostic upper endoscopy, up to 1 hour	Time to complete the upper endoscopy (from the time of oral intubation until complete removal of the endoscope)
Incidence of adverse events	up to 1 week	Number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.

Trial Locations

Locations (5)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, 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; 🇨🇳 Huhehot, Inner Mongolia Autonomous Region, China