Trials / Active Not Recruiting
Active Not RecruitingNCT06722664
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.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- Sponsor
- Healthgen Biotechnology Corp. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-12-19
- Primary completion
- 2025-05-15
- Completion
- 2025-05-15
- First posted
- 2024-12-09
- Last updated
- 2025-04-29
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06722664. Inclusion in this directory is not an endorsement.