Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients

• Status: Completed
• Trial end date: 2020-01-11
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of the study:

To obtain additional data on efficacy and safety of Kolofort in functional dyspepsia patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

Criteria

Inclusion Criteria:

1. Men and women aged 18-45 years.

2. Diagnosis of functional dyspepsia, based on the Rome IV criteria (2016).

3. GIS score of at least 6.

4. Negative H. pylori test .

5. Availability of a signed patient information sheet (Informed Consent form) for participation in the clinical trial.

6. Patients who agree to use an effective method of contraception throughout the clinical trial.

Exclusion Criteria:

1. Organic diseases of the gastrointestinal tract (gastro-oesophageal reflux disease (GERD), ulcer, chronic pancreatitis, cholelithiasis, fatty liver disease, hepatitis, cirrhosis of liver, etc.) .

2. Diagnosis of other functional diseases of the digestive system, such as dyskinesia of cystic duct or gallbladder, irritable bowel syndrome, etc.

3. Discontinuation of proton pump inhibitors, propulsives, antispasmodics, antacids, or bismuth preparations less than 7 days prior to randomization.

4. H. Pylori eradication within 2 months before study entry.

5. Intestinal infection within 2 months before study entry.

6. Known history of/suspected malignant neoplasm of various sites.

7. Prior diagnosis of a class IV cardiovascular disease (according to the New York Heart Association, 1964), hypothyroidism, diabetes mellitus, chronic kidney disease (С3-5), or disease of liver with portal hypertension and/or severe decompensation (Child-Pugh score > 6).

8. Other severe coexisting morbidity which, in the investigator's opinion, can prevent the patient from participating in the study.

9. Allergy/intolerance to any of the components of medications used in the treatment.

10. Pregnancy, breast-feeding.

11. Patients who, from investigator's point of view, will fail to comply with the observation requirements of the trial or with the dosing regimen of the investigational drugs.

12. Planned hospitalization during the study period, for any diagnostic or treatment procedures.

13. Drug addiction, alcohol use in the amount over 2 units of alcohol a day, mental diseases.

14. Intake of medicines listed in the section 'Prohibited concomitant treatment' for 1 month prior to the enrollment in the trial.

15. Participation in other clinical trials within 3 months to the enrollment in this study.

16. Patient is related to the research staff of the clinical investigative site who are directly involved in the trial or is the immediate family member of the investigator. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.

17. Patient works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., is the company's employee, temporary contract worker or appointed official responsible for carrying out the research or their immediate family).