Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
- 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.
- Short title
- Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
- 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.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-05-15
- First posted
- 2024-12-09
- Registry last updated
- 2025-04-29
- Primary completion date
- 2025-05-15
- Start date
- 2024-12-19
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Healthgen Biotechnology Corp.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06722664
- ClinicalTrials.gov ID
- NCT06722664
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Diagnosis
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Total visibility score (TVS) evaluated by blinded endoscopists
Timeframe: 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.
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach
Timeframe: 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
Timeframe: during diagnostic upper endoscopy, up to 1 hour
Amount of water used to allow an suitable visualization of gastric mucosa
Duration of endoscopy
Timeframe: 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
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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;
- 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.
- Beijing Friendship HospitalBeijing, China
- Chinese PLA Central Theatre General HospitalWuhan, China
- Renmin Hospital of Wuhan UniversityWuhan, China
- the Central Hospital of WuhanWuhan, China
- Inner Mongolia Autonomous Region People's HospitalHohhot, China
Related records
Drugs (2)
Collaborators (1)
- Beijing Friendship Hospital