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

NCT06722664 | Active Not Recruiting Phase 2

• 1 other identifier: HY1005-1-2024-P2
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 5

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.

Conditions

Gastric Mucosal Lesion

Keywords

OsrhCT; Recombinant Human Chymotrypsin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach

  Through study completion, an average of 3 months

• The amount of water flushed for satisfactory observation of the upper gastrointestinal tract

  during diagnostic upper endoscopy, up to 1 hour

• Duration of endoscopy

  during diagnostic upper endoscopy, up to 1 hour

• Incidence of adverse events

  up to 1 week

Other Outcomes (1)

• Establishment and method validation of the criteria for mucosal visibility score

  Through study completion, an average of 3 months

Study Arms (3)

Recombinant Human Chymotrypsin(OsrhCT) 4000U

EXPERIMENTAL

Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT); Drug: Dimethicone emulsion 4ml

Recombinant Human Chymotrypsin(OsrhCT) 8000U

EXPERIMENTAL

Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Drug: Dimethicone emulsion 4ml

Placebo for Recombinant Human Chymotrypsin(OsrhCT)

PLACEBO COMPARATOR

Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT); Drug: Dimethicone emulsion 4ml

Interventions

Recombinant Human Chymotrypsin(OsrhCT) 4000U DRUG

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

Recombinant Human Chymotrypsin(OsrhCT) 4000U; Recombinant Human Chymotrypsin(OsrhCT) 8000U

Placebo for Recombinant Human Chymotrypsin(OsrhCT) DRUG

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

Placebo for Recombinant Human Chymotrypsin(OsrhCT); Recombinant Human Chymotrypsin(OsrhCT) 4000U

Dimethicone emulsion 4ml DRUG

Dimethicone emulsion，produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle.

Placebo for Recombinant Human Chymotrypsin(OsrhCT); Recombinant Human Chymotrypsin(OsrhCT) 4000U; Recombinant Human Chymotrypsin(OsrhCT) 8000U

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients indicated for gastroscopy examination;
• Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent;
• Able to complete the research according to the requirements of the experimental plan;
• 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;
• Aged 18-75 years (inclusive), male or female;

You may not qualify if:

• Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination;
• Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc;
• Subjects accessed not to stand sedation anesthesia or gastroscopy examination;
• Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices;
• Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery;
• Abnormal laboratory values:: alanine aminotransferase (ALT)\>2 × ULN, aspartate aminotransferase (AST)\>2 × ULN, serum creatinine\>1.5 × ULN;
• Female subjects who had unprotected sex within 14 days prior to screening;
• Pregnant or breastfeeding women;
• Subjects who have participated in any drug clinical trial and received treatment within the last 3 months;
• Any other conditions deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Healthgen Biotechnology Corp.: lead
• Beijing Friendship Hospital: collaborator

Study Sites (5)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

Chinese PLA Central Theatre General Hospital

Wuhan, Hubei, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

the Central Hospital of Wuhan

Wuhan, Hubei, China

Location

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Location

Study Officials

• Shutian Zhang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Fandong Meng, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 9, 2024
• Study Start: December 19, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: April 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)