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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 : Completed
First Posted : April 19, 2017
Last Update Posted : February 20, 2020
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

Detailed Description:

Design: a double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of the therapy.

The study will include patients of both genders aged 18 - 45 years with a diagnosis of functional dyspepsia according to Rome IV diagnostic criteria and the severity of dyspepsia symptoms of at least 6 points on the GIS scale (Gastrointestinal symptom score - Gastrointestinal symptoms scale).

At the screening visit (Visit 1, from -14 to -1 days), after signing the patient information sheet (informed consent form) to participate in the clinical trial, patients complaints and medical history are collected, and an objective examination is conducted. The investigator assesses the severity of dyspepsia symptoms on a GIS scale. The patient undergoes an ultrasound examination of the abdominal organs, endoscopy and Helicobacter pylori (H. pylori) infection tests. With the previous intake of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth preparations, the doctor evaluates the possibility of discontinuing these drugs at least 7 days before the patient's randomization. Women of reproductive age undergo a pregnancy test.

On the day of randomization (Visit 2, Day 0) patient complaints are collected, an objective examination is conducted. The doctor evaluates the results of the conducted laboratory tests and instrumental methods of diagnosis, assesses the severity of symptoms of dyspepsia on the GIS scale, records changes in concomitant therapy.

If the inclusion criteria are met and the absence of non-inclusion criteria is met, the patient is randomized into one of two groups: patients of group 1 receive Kolofort for 8 weeks; Group 2 patients receive a placebo according to the study drug regimen. The patient fills out questionnaires to evaluate the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36).

Patient treatment lasts 8 weeks, during which 3 visits are made to the investigational site . At Visit 3 (Week 2 ± 3 days), complaints are collected and an objective examination of the patient is carried out. The doctor monitors the prescribed and concomitant therapy, assesses the safety of therapy and the degree of adherence to treatment (compliance). During visit 4 (Week 4 ± 3 days) and 5 (Week 8 ± 3 days), the doctor obtains patients complaints, records objective examination data, monitors prescribed and concomitant therapy, assesses the safety of the treatment and the patient's degree of adherence to the studied therapy (compliance) . GIS, NDI questionnaires are filled in.

Additionally, at visit 5, the patient fills in the SF-36 scale, the doctor fills in the Clinical Global Impression-Efficacy Index (CGI-EI).

In one center (Clinic for Propaedeutics of Internal Medicine, Gastroenterology and Hepatology named after V. Kh. Vasilenko of the First Moscow State Medical University named after IM Sechenov), a hydrogen breathing test (H2 test) will be conducted on Visit 2 and Visit 5 to evaluate an additional effectiveness criterion .

During the study period, concomitant therapy is allowed, with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : January 11, 2020
Actual Study Completion Date : January 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Kolofort
Oral. Single dose: 2 tablets. Dose regimen: 2 tablets twice daily (4 tablets a day). Tablets should be held in the mouth until dissolution is complete; not to be taken concomitantly with food.
Drug: Kolofort
Safety and Efficiency

Placebo Comparator: Placebo
Oral. Single dose: 2 tablets. Dose regimen: 2 tablets twice daily (4 tablets a day). Tablets should be held in the mouth until dissolution is complete; not to be taken concomitantly with food.
Drug: Placebo
Safety and Efficiency




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


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

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

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

  4. The proportion of patients who has withdrawn from study participation 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 week 8 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 week 8 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.


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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 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).

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
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Sponsors and Collaborators
Materia Medica Holding
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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03119766    
Other Study ID Numbers: MMH-KOL-003
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: June 2019

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