Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 31
- 主要终点
- Changes in Severity of Functional Dyspepsia Symptoms
研究概览
简要总结
Purpose of the study:
To obtain additional data on efficacy and safety of Kolofort in the treatment of patients with functional dyspepsia.
详细描述
Design: a multicenter double-blind placebo-controlled randomized clinical trial to evaluate the efficacy and safety of the study treatment.
The study will enroll the patients of both genders aged 18-45 years old with verified diagnosis of "functional dyspepsia" according to Rome-IV criteria and intensity of dyspeptic symptoms ≥ 6 according to GIS (Gastrointestinal symptom score).
At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information sheet (informed consent form) to participate in the clinical trial, complaints and medical history are collected, an objective examination is performed. The investigator evaluates intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of canceling these drugs at least 7 days before the patient is randomized. For women of reproductive age, a pregnancy test is performed.
On the day of randomization (Visit 2, Day 0) collection of complaints and objective examination are carried out. The investigator evaluates the results of laboratory and instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers changes in concomitant therapy.
If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia Index (NDI) and Quality of Life (SF-36) questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Use of any medications specified in the "Prohibited Concomitant Treatment" within 1 month prior to inclusion in the study.
- •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).
- •Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
研究组 & 干预措施
Kolofort
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.
干预措施: Kolofort (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Severity of Functional Dyspepsia Symptoms
时间窗: On baseline, after 4 and 8 weeks of the treatment
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.
次要结局
- 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)