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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005747-23-CZ

Enrollment

120

Registered

2021-02-04

Start date

2021-05-05

Completion date

Unknown

Last updated

2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visibility mucosal score during upper endoscopy after administration of mucolytic solution

Interventions

Trade Name: ACC 200 NEO Product Name: ACC 200 NEO Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLCYSTEINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Visibility score" evaluated by blinded performing endoscopist 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 "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 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	—

Measure

Time frame

Main Objective: Visibility score" evaluated by blinded performing endoscopist 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 "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 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

Measure	Time frame
Secondary end point(s): Visibility score" evaluated by two blinded endoscopists using 10 endoscopic images captured during endoskopy "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	—

Countries

Czech Republic

Contacts

Public ContactMichal Štepán M.D

Nemocnice Agel OStrava Vítkovice

stepan.michal@seznam.cz+420596633207

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026