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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03119766
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : October 15, 2018
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

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 2019
Estimated Study Completion Date : May 2019

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.


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


Contacts
Contact: Mikhail Putilovskiy, MD +74952761571 ext 302 PutilovskiyMA@materiamedica.ru

Locations
Russian Federation
Municipal Budgetary Institution "Central City Hospital No. 7" Active, not recruiting
Ekaterinburg, Russian Federation, 620137
State budget institution of health care of the Moscow region "Krasnogorsk city hospital №1" Not yet recruiting
Krasnogorsk, Russian Federation, 143408
Contact: Svetlana Erofeeva, MD, PhD         
Principal Investigator: Svetlana Erofeeva, MD, PhD         
The State Budgetary Healthcare Institution of Moscow The Moscow Clinical Scientific and Practical Center of the Moscow City Health Department Recruiting
Moscow, Russian Federation, 111123
Contact: Dmitrij Bordin         
Principal Investigator: Dmitrij Bordin         
Federal State Budgetary Institution Federal Research and Clinical Center for Specialized Medical Assistance and Medical Technologies of the Federal Medical Biological Agency of Russia Recruiting
Moscow, Russian Federation, 115682
Contact: Oksana Novikova, MD         
Principal Investigator: Oksana Novikova, MD         
The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences Completed
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 Recruiting
Moscow, Russian Federation, 119991
Contact: Mikhail Osadchuk, Prof         
Principal Investigator: Mikhail Osadchuk, Prof         
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 Recruiting
Moscow, Russian Federation, 119992
Contact: Aleksandr Truhmanov, Prof.         
Principal Investigator: Aleksandr Truhmanov, Prof         
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital No. 51 of the Moscow City Health Department" Recruiting
Moscow, Russian Federation, 121309
Contact: Oleg Minushkin, MD, PhD         
Principal Investigator: Oleg Minushkin, MD, PhD         
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 Recruiting
Moscow, Russian Federation, 127473
Contact: Igor' Maev, Prof         
Principal Investigator: Igor' Maev, Prof         
Federal State Budgetary Institution "Polyclinic No. 3" of the Administration of the President of the Russian Federation Recruiting
Moscow, Russian Federation, 129090
Contact: Sergey Burkov, MD         
Principal Investigator: Sergey Burkov, MD         
Private Healthcare Institution "The Road Clinical Hospital at the Nizhny Novgorod station of the open joint-stock company" Russian Railways " Recruiting
Nizhny Novgorod, Russian Federation, 603140
Contact: Natalia Eremina, MD         
Principal Investigator: Natalia Eremina, MD         
Novosibirsk State Medical University Recruiting
Novosibirsk, Russian Federation, 630091
Contact: Marina Osipenko, MD         
Principal Investigator: Marina Osipenko, MD         
State budgetary healthcare institution of the Moscow region "Podil'skaya City Clinical Hospital No. 3" Recruiting
Podol'sk, Russian Federation, 142105
Contact: Marina Chernogorova, MD, PhD         
Principal Investigator: Marina Chernogorova, MD, PhD         
State Autonomous Healthcare Institution of the Moscow Region "Central City Clinical Hospital in Reutov" Not yet recruiting
Reutov, Russian Federation, 143964
Contact: Natalia Peretyatkina, MD         
Principal Investigator: Natalia Peretyatkina, MD         
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic №38" Recruiting
Saint Petersburg, Russian Federation, 191015
Contact: Boris Starostin, MD         
Principal Investigator: Boris Starostin, MD         
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 Recruiting
Saint Petersburg, Russian Federation, 191015
Contact: Igor' Bakulin, Prof         
Principal Investigator: Igor' Bakulin, Prof         
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 Recruiting
Saint Petersburg, Russian Federation, 194044
Contact: Vladimir Grinevich, Prof         
Principal Investigator: Vladimir Grinevich, Prof         
St. Petersburg State Budgetary Healthcare Institution "City Hospital of the Holy Martyr Elizabeth" Completed
Saint Petersburg, Russian Federation, 195257
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 26" Completed
Saint Petersburg, Russian Federation, 196247
Saratov State Medical University named after V. I. Razumovsky Recruiting
Saratov, Russian Federation, 410054
Contact: Yurij Schwartz, Prof         
Principal Investigator: Yurij Schwartz, Prof         
State Health Care Institution "Regional Clinical Hospital" Not yet recruiting
Tver, Russian Federation, 170036
Contact: Veronica Leontyeva, MD         
Principal Investigator: Veronica Leontyeva, MD         
Sponsors and Collaborators
Materia Medica Holding

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: October 15, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms