Gastric Mucosal LesionPhase 2NCT06722664
Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
A Phase 2 study testing Recombinant Human Chymotrypsin(OsrhCT) 4000U and Dimethicone emulsion 4ml in people with Gastric Mucosal Lesion, run by Healthgen Biotechnology Corp. at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Mucosal Lesion
- What is being tested?
- Recombinant Human Chymotrypsin(OsrhCT) 4000U and Dimethicone emulsion 4ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 5 sitesChina
- Study dates
- 19 Dec 2024to 15 May 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Friendship Hospital
Beijing, Beijing Municipality
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia
Chinese PLA Central Theatre General Hospital
Wuhan, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei
the Central Hospital of Wuhan
Wuhan, Hubei
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Mucosal Lesion
- Being tested
- Recombinant Human Chymotrypsin(OsrhCT) 4000U, Placebo for Recombinant Human Chymotrypsin(OsrhCT), Dimethicone emulsion 4ml
- Keywords
- OsrhCT, Recombinant Human Chymotrypsin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Chymotrypsin(OsrhCT) 4000UDrug
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder
Placebo for Recombinant Human Chymotrypsin(OsrhCT)Drug
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/vial, freeze-dried powder
Dimethicone emulsion 4mlDrug
Dimethicone emulsion，produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Chymotrypsin(OsrhCT) 4000U | Experimental | Not described Receives: Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT); Drug: Dimethicone emulsion 4ml |
| Recombinant Human Chymotrypsin(OsrhCT) 8000U | Experimental | Not described Receives: Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U; Drug: Dimethicone emulsion 4ml |
| Placebo for Recombinant Human Chymotrypsin(OsrhCT) | Placebo comparator | Not described Receives: Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT); Drug: Dimethicone emulsion 4ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus.
Measured: 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
Measured: 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)
Measured: 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.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start19 Dec 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Mucosal LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthgen Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Shutian Zhang, MD, Principal investigator, Beijing Friendship HospitalFandong Meng, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722664
- Sponsor's protocol ID
- HY1005-1-2024-P2
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06722664
- Acronym / sponsor ID
- HY1005-1-2024-P2
- Conditions
- Gastric Mucosal Lesion
- Keywords
- OsrhCT, Recombinant Human Chymotrypsin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Healthgen Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Chymotrypsin(OsrhCT) 4000URecombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder | Drug | Recombinant Human Chymotrypsin(OsrhCT) 4000U, Recombinant Human Chymotrypsin(OsrhCT) 8000U |
| Placebo for Recombinant Human Chymotrypsin(OsrhCT)Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/vial, freeze-dried powder | Drug | Placebo for Recombinant Human Chymotrypsin(OsrhCT), Recombinant Human Chymotrypsin(OsrhCT) 4000U |
| Dimethicone emulsion 4mlDimethicone emulsion，produced by Sichuan Jian Neng Pharmaceutical Co., Ltd, 6ml/bottle. | Drug | Placebo for Recombinant Human Chymotrypsin(OsrhCT), Recombinant Human Chymotrypsin(OsrhCT) 4000U, Recombinant Human Chymotrypsin(OsrhCT) 8000U |
Primary outcome
Total visibility score (TVS) evaluated by blinded endoscopists
Time frame: 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.
4 secondary outcomes
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach
Time frame: Through study completion, an average of 3 months
The amount of water flushed for satisfactory observation of the upper gastrointestinal tract
Time frame: during diagnostic upper endoscopy, up to 1 hour
Duration of endoscopy
Time frame: during diagnostic upper endoscopy, up to 1 hour
Incidence of adverse events
Time frame: up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Gastric Mucosal Lesion
Not yet recruitingPhase 2
Efficacy and Safety of OsrhCT Before Upper Endoscopy on Improving Visualization of the Gastric Mucosa.
Gastric Mucosal Lesion
RecruitingObservational study
Association Between Microplastic Exposure and the Pathological Progression of Gastric Carcinogenesis
Gastric Carcinoma, Gastritis Chronic
Not yet recruitingObservational study
Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions
Early Gastric Cancer
Recruiting
Argon Plasma Coagulation Versus Endoscopic Mucosal Resection for Gastric Adenoma (CLER-GA)
Gastric Adenoma, Stomach Neoplasms
Recruiting
Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection (ESD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shutian Zhang, MD principal investigator
Beijing Friendship Hospital
Fandong Meng, MD principal investigator
Beijing Friendship Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Chymotrypsin(OsrhCT) 4000U and Dimethicone emulsion 4ml in people with Gastric Mucosal Lesion, run by Healthgen Biotechnology Corp. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total visibility score (TVS) evaluated by blinded endoscopists (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.