se of mucolytic solution before gastroscopy, double-blind, randomized study

Phase 1

Conditions: Visibility mucosal score during upper endoscopy after administration of mucolytic solution
Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]

Registration Number: EUCTR2020-005747-23-CZ

Lead Sponsor: emocnice Agel Ostrava-Vítkovice a.s.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- age > 18 years, signed informed consent, diagnostic gastroscopy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- age < 18 years, interventional gastroscopy, known disease of the upper GI tract and/or history of surgery of GI tract, gastroscopy indicated of bleeding, dysphagia or ileus, liver cirrhosis, general anesthesia, allergy to mucolytic solution components, pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Visibility score evaluated by blinded performing endoscopist<br>Visibility score (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).;Secondary Objective: Visibility score evaluated by two blinded endoscopists using 10 endoscopic images captured during endoskopy<br>Visibility score (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).;Primary end point(s): Visibility score evaluated by blinded performing endoscopist<br>Visibility score (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).;Timepoint(s) of evaluation of this end point: 5 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Visibility score evaluated by two blinded endoscopists using 10 endoscopic images captured during endoskopy<br>Visibility score (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).;Timepoint(s) of evaluation of this end point: 5 months