Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-27 @ 12:48 AM
Study NCT ID:
NCT03119766
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients
Sponsor:
Materia Medica Holding
Organization:
Study Overview
Official Title:
Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the study:
To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.
To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.
Detailed Description:
Design: a multicenter double-blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of the study treatment.
The study will enroll the patients of both genders aged 18-45 years old with verified diagnosis of "functional dyspepsia" according to Rome-IV criteria and intensity of dyspeptic symptoms ≥ 6 according to GIS (Gastrointestinal symptom score).
At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information sheet (informed consent form) to participate in the clinical trial, complaints and medical history are collected, an objective examination is performed. The investigator evaluates intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of canceling these drugs at least 7 days before the patient is randomized. For women of reproductive age, a pregnancy test is performed.
On the day of randomization (Visit 2, Day 0) collection of complaints and objective examination are carried out. The investigator evaluates the results of laboratory and instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers changes in concomitant therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36) questionnaires.
The patient's treatment lasts for 8 weeks, during which 3 visits to the research center are carried out. At Visit 3 (Week 2 ± 3 days), complaints are collected, an objective examination of the patient is performed. The investigator monitors the prescribed and concomitant therapy, evaluates the safety of therapy and the degree of adherence to treatment (compliance). At visit 4 (week 4±3 days) and 5 (week 8±3 days) the investigator collects complaints, registers the physical examination data, monitors the prescribed and concomitant therapy, assesses the safety of the treatment and compliance. Questionnaires GIS, NDI are filled in.
Additionally, at Visit 5 the patient fills out the SF-36 scale, the investigator fills out the Clinical Global Impression-Efficacy Index (CGI-EI).
The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Prohibited Concomitant Treatment".
The study will enroll the patients of both genders aged 18-45 years old with verified diagnosis of "functional dyspepsia" according to Rome-IV criteria and intensity of dyspeptic symptoms ≥ 6 according to GIS (Gastrointestinal symptom score).
At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information sheet (informed consent form) to participate in the clinical trial, complaints and medical history are collected, an objective examination is performed. The investigator evaluates intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of canceling these drugs at least 7 days before the patient is randomized. For women of reproductive age, a pregnancy test is performed.
On the day of randomization (Visit 2, Day 0) collection of complaints and objective examination are carried out. The investigator evaluates the results of laboratory and instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers changes in concomitant therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36) questionnaires.
The patient's treatment lasts for 8 weeks, during which 3 visits to the research center are carried out. At Visit 3 (Week 2 ± 3 days), complaints are collected, an objective examination of the patient is performed. The investigator monitors the prescribed and concomitant therapy, evaluates the safety of therapy and the degree of adherence to treatment (compliance). At visit 4 (week 4±3 days) and 5 (week 8±3 days) the investigator collects complaints, registers the physical examination data, monitors the prescribed and concomitant therapy, assesses the safety of the treatment and compliance. Questionnaires GIS, NDI are filled in.
Additionally, at Visit 5 the patient fills out the SF-36 scale, the investigator fills out the Clinical Global Impression-Efficacy Index (CGI-EI).
The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Prohibited Concomitant Treatment".
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: