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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Mucosal Lesion
• Intervention / Treatment: Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT); Drug: Dimethicone emulsion 4ml

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 Type: Interventional
• Enrollment (Estimated): 336
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Friendship Hospital
  • Hubei
    • Wuhan, Hubei, China
      • The Central Hospital of Wuhan
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Chinese PLA Central Theatre General Hospital
  • Inner Mongolia Autonomous Region
    • Huhehot, Inner Mongolia Autonomous Region, China
      • Inner Mongolia Autonomous Region People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recombinant Human Chymotrypsin(OsrhCT) 4000U	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.
Experimental: Recombinant Human Chymotrypsin(OsrhCT) 8000U	Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder; Drug: Dimethicone emulsion 4ml; Dimethicone emulsion，produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle.
Placebo Comparator: Placebo for Recombinant Human Chymotrypsin(OsrhCT)	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach	Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus.	Through study completion, an average of 3 months
The amount of water flushed for satisfactory observation of the upper gastrointestinal tract	Amount of water used to allow an suitable visualization of gastric mucosa	during diagnostic upper endoscopy, up to 1 hour
Duration of endoscopy	Time to complete the upper endoscopy (from the time of oral intubation until complete removal of the endoscope)	during diagnostic upper endoscopy, up to 1 hour
Incidence of adverse events	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.	up to 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment and method validation of the criteria for mucosal visibility score	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 (lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum) evaluated by a blinded endoscopist and subsequently by two or three blinded endoscopists.	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Healthgen Biotechnology Corp.
• Collaborators: Beijing Friendship Hospital
• Investigators: Principal Investigator: Shutian Zhang, MD, Beijing Friendship Hospital; Principal Investigator: Fandong Meng, MD, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: OsrhCT; Recombinant Human Chymotrypsin
• Other Study ID Numbers: HY1005-1-2024-P2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No