Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119766
Recruitment Status : Active, not recruiting
First Posted : April 19, 2017
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Brief Summary:

Purpose of the study:

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


Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Kolofort Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Kolofort Drug: Kolofort
Safety and Efficiency

Placebo Comparator: Placebo Drug: Placebo
Safety and Efficiency




Primary Outcome Measures :
  1. Changes of functional dyspepsia symptoms severity in GIS (Gastrointestinal symptom score) at 8 weeks from study treatment initiation [ Time Frame: in 8 weeks of the treatment ]
    Gastrointestinal symptom score


Secondary Outcome Measures :
  1. Percentage of patients with a lower severity of functional dyspepsia symptoms in GIS score at 8 weeks from study treatment initiation [ Time Frame: in 8 weeks of the treatment ]
    Gastrointestinal symptom score

  2. Changes in NDI score at 8 weeks from study treatment initiation [ Time Frame: in 8 weeks of the treatment ]
    NDI score

  3. Changes in SF-36 score at 8 weeks from study treatment initiation [ Time Frame: in 8 weeks of the treatment ]
    SF-36 score

  4. Percentage of patients withdrawing early due to lack of efficacy of the investigational treatment [ Time Frame: in 8 weeks of the treatment ]
    Number of patients

  5. Measures of therapeutic and adverse effects, the efficiency on the scale of CGI-EI (Clinical Global Impression-Efficacy Index) at 8 weeks from study treatment initiation [ Time Frame: in 8 weeks of the treatment ]
    CGI-EI score


Other Outcome Measures:
  1. Changes in oro-cecal transit time assessed by the hydrogen breath test, at 8 weeks from the study treatment initiation [ Time Frame: in 8 weeks of the treatment ]
    transit time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 digestive system (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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119766


Locations
Layout table for location information
Russian Federation
South Ural State University
Chelyabinsk, Russian Federation, 454092
Municipal Budgetary Institution "Central City Hospital No. 7"
Ekaterinburg, Russian Federation, 620137
Ivanovo Clinical Hospital named after Kuvaev
Ivanovo, Russian Federation, 153025
State budget institution of health care of the Moscow region "Krasnogorsk city hospital №1"
Krasnogorsk, Russian Federation, 143408
The State Budgetary Healthcare Institution of Moscow The Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
Moscow, Russian Federation, 111123
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, Russian Federation, 115682
The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
Moscow, Russian Federation, 117593
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, Russian Federation, 119991
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, Russian Federation, 119992
National Medical Research Center for Rehabilitation and Health Resort
Moscow, Russian Federation, 121099
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 51 of the Moscow City Health Department"
Moscow, Russian Federation, 121309
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, Russian Federation, 127473
Federal State Budgetary Institution "Polyclinic No. 3" of the Administration of the President of the Russian Federation
Moscow, Russian Federation, 129090
Private Healthcare Institution "The Road Clinical Hospital at the Nizhny Novgorod station of the open joint-stock company" Russian Railways "
Nizhny Novgorod, Russian Federation, 603140
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630091
State budgetary healthcare institution of the Moscow region "Podolsk City Clinical Hospital No. 3"
Podol'sk, Russian Federation, 142105
State Autonomous Healthcare Institution of the Moscow Region "Central City Clinical Hospital in Reutov"
Reutov, Russian Federation, 143964
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic №38"
Saint Petersburg, Russian Federation, 191015
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, Russian Federation, 191015
City Mariinsky Hospital
Saint Petersburg, Russian Federation, 194014
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, Russian Federation, 194044
St. Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"
Saint Petersburg, Russian Federation, 195257
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 26"
Saint Petersburg, Russian Federation, 196247
Limited Liability Company Gastroenterologichesky Center Expert
Saint Petersburg, Russian Federation, 197110
Samara City Hospital #4
Samara, Russian Federation, 443056
LLC Medical company "Hepatologist"
Samara, Russian Federation, 443063
Saratov State Medical University named after V. I. Razumovsky
Saratov, Russian Federation, 410054
Saratov City Clinical Hospital #5
Saratov, Russian Federation, 410071
St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"
Sestroretsk, Russian Federation, 197706
Stavropol Regional Clinical Consultative and Diagnostic Center
Stavropol, Russian Federation, 355017
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russian Federation, 432063
State Autonomous Healthcare Institution of the Yaroslavl Region "N.V. Clinical Emergency Hospital Solovyov "
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Materia Medica Holding

Layout table for additonal information
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03119766     History of Changes
Other Study ID Numbers: MMH-KOL-003
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms