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

NCT03119766 | Completed Phase 4 Results

• 1 other identifier: MMH-KOL-003
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 32

Brief Summary

Purpose of the study: To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Changes in Severity of Functional Dyspepsia Symptoms

  Changes in severity of functional dyspepsia symptoms due to GIS score (Gastrointestinal symptom score) at week 8 from the start of study therapy. The GIS scale includes 10 subscales (symptoms), the severity of each one was evaluated from 0 to 4 points (by Lickert scale).For example, the absence of the mentioned symptom is classified as "0". The most severe is classified as "4". The all 10 subscales were combined to compute a total score. So the total range is a sum of all subscales.The total score is in range from 0 till 40. So the minimum value is 0, the maximum is 40.

  On baseline, after 4 and 8 weeks of the treatment

Secondary Outcomes (5)

• Percentage of Patients With a Decrease in the Severity of FD Symptoms

  After 8 weeks of the treatment

• Change in the Severity of the Functional Dyspepsia Index NDI (Nepean Dyspepsia Index)

  On baseline, after 4 and 8 weeks of the treatment

• Changes in the Quality of Life of Patients on the SF-36 (Short Form-36) Health Survey Scale

  On baseline and after 8 weeks of the treatment

• Percentage of Patients Terminating the Study Early

  in 8 weeks of the treatment

• Indicators of Therapeutic and Side Effects, Efficacy Index on CGI-EI (Clinical Global Impression-Efficacy Index) Scale

  After 8 weeks of the treatment

Study Arms (2)

Kolofort

EXPERIMENTAL

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.

Drug: Kolofort

Placebo

PLACEBO COMPARATOR

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.

Drug: Placebo

Interventions

Kolofort DRUG

Oral administration

Kolofort

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both genders aged 18-45 years old.
• Diagnosis of functional dyspepsia established according to Rome-IV criteria (2016).
• Severity of symptoms of dyspepsia ≥ 6 on the GIS scale.
• Negative test result for H. pylori infection .
• Availability of signed patient information sheet and informed consent form for participation in the clinical trial.
• Patients who gave their consent to use reliable contraception during the study

You may not qualify if:

• Organic diseases of the gastrointestinal tract (gastroesophageal reflux disease (GERD), peptic ulcer, chronic pancreatitis, cholelithiasis, hepatosis, hepatitis, hepatic cirrhosis, etc.)
• Verified diagnosis of other functional GI diseases, i.e. biliary dyskinesia, irritable bowel syndrome, etc.
• Discontinuation of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth preparations less than 7 days before randomization.
• H. pylori eradication within 2 months prior to enrollment.
• Intestinal infection within 2 months prior to enrollment.
• History/suspicion of oncology of any location.
• Previously diagnosed cardiovascular diseases with functional class IV (according to the classification of the New-York Heart Association, 1964), hypothyroidism, diabetes mellitus, chronic renal disease С3-5, hepatic diseases with portal hypertension and/or signs of severe decompensation of function (\> 6 points according to the Child-Pugh classification).
• Any other severe comorbidity that, in the opinion of the investigator, may affect patient participation in the clinical trial.
• Allergy/intolerance intolerances to any of the components of the study drugs.
• Pregnancy, breast-feeding.
• Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens.
• Scheduled hospitalization during the study for any diagnostic or therapeutic procedures.
• Use of drugs or alcohol (more than 2 alcohol units daily), presence of mental diseases.
• Participation in other clinical trials in the previous 3 months.
• Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (32)

South Ural State University

Chelyabinsk, 454092, Russia

Location

Ivanovo Clinical Hospital named after Kuvaev

Ivanovo, 153025, Russia

Location

State budget institution of health care of the Moscow region "Krasnogorsk city hospital №1"

Krasnogorsk, 143408, Russia

Location

The State Budgetary Healthcare Institution of Moscow The Moscow Clinical Scientific and Practical Center of the Moscow City Health Department

Moscow, 111123, Russia

Location

Federal State Budgetary Institution Federal Research and Clinical Center for Specialized Medical Assistance and Medical Technologies of the Federal Medical Biological Agency of Russia

Moscow, 115682, Russia

Location

The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care of the Russian Federation

Moscow, 119991, Russia

Location

The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care of the Russian Federation

Moscow, 119992, Russia

Location

National Medical Research Center for Rehabilitation and Health Resort

Moscow, 121099, Russia

Location

State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 51 of the Moscow City Health Department"

Moscow, 121309, Russia

Location

Federal State Budgetary Educational Institution of the Higher Education "A.I. Yevdokimov Moscow State University of Medicine and Dentistry" of the Ministry of Healthcare of the Russian Federation

Moscow, 127473, Russia

Location

Federal State Budgetary Institution "Polyclinic No. 3" of the Administration of the President of the Russian Federation

Moscow, 129090, Russia

Location

Private Healthcare Institution "The Road Clinical Hospital at the Nizhny Novgorod station of the open joint-stock company" Russian Railways "

Nizhny Novgorod, 603140, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Location

State budgetary healthcare institution of the Moscow region "Podolsk City Clinical Hospital No. 3"

Podol’sk, 142105, Russia

Location

State Autonomous Healthcare Institution of the Moscow Region "Central City Clinical Hospital in Reutov"

Reutov, 143964, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic №38"

Saint Petersburg, 191015, Russia

Location

State budget institution of higher education "North-Western State Medical University named after I.I Mechnikov" under the Ministry of Public Health of the Russian Federation

Saint Petersburg, 191015, Russia

Location

City Mariinsky Hospital

Saint Petersburg, 194014, Russia

Location

Federal state budget military educational institution of higher professional education "Military Medical Academy named after S.Kirov" of the Ministry of Defense of the Russian Federation

Saint Petersburg, 194044, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"

Saint Petersburg, 195257, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 26"

Saint Petersburg, 196247, Russia

Location

Limited Liability Company Gastroenterologichesky Center Expert

Saint Petersburg, 197110, Russia

Location

Samara City Hospital #4

Samara, 443056, Russia

Location

LLC Medical company "Hepatologist"

Samara, 443063, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410054, Russia

Location

Saratov City Clinical Hospital #5

Saratov, 410071, Russia

Location

St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"

Sestroretsk, 197706, Russia

Location

Stavropol Regional Clinical Consultative and Diagnostic Center

Stavropol, 355017, Russia

Location

State Healthcare Institution Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

Location

State Autonomous Healthcare Institution of the Yaroslavl Region "N.V. Clinical Emergency Hospital Solovyov "

Yaroslavl, 150003, Russia

Location

Municipal Budgetary Institution "Central City Hospital No. 7"

Yekaterinburg, 620137, Russia

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 19, 2017
• Study Start: June 28, 2017
• Primary Completion: January 11, 2020
• Study Completion: January 11, 2020
• Last Updated: June 7, 2022
• Results First Posted: June 7, 2022

Record last verified: 2019-06

Locations

RU (32)