Multicenter Double-blind Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of Kolofort in the Treatment of Patients With Functional Dyspepsia

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

开始日期2017-06-28

申办/合作机构

OOO NPF Materia Medica Holding

100 项与 Kolofort 相关的临床结果

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100 项与 Kolofort 相关的转化医学

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100 项与 Kolofort 相关的专利（医药）

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项与 Kolofort 相关的文献（医药）

2020-12-01·BMC Gastroenterology3区 · 医学

Pathogenetic approach to the treatment of functional disorders of the gastrointestinal tract and their intersection: results of the Russian observation retrospective program COMFORT

3区 · 医学

ArticleOA

作者: Glazunov, Alexey B ; Epstein, Oleg I ; Ivashkin, Vladimir T ; Putilovskiy, Mikhail A ; Poluektova, Elena A

AbstractBackgroundThe aim of this study was to investigate the efficacy and safety of the novel complex drug, consisting of released-active form of antibodies to S-100 protein, tumor necrosis factor-α and histamine, (Kolofort) under outpatient conditions in patients with functional dyspepsia (FD), irritable bowel syndrome (IBS), and FD-IBS overlap.MethodsThe subjects of the observational noninterventional retrospective program were the data of 14,362 outpatient records of patients with diagnosed FD, IBS, and/or overlap, who were observed by gastroenterologists from November 01, 2017, through March 30, 2018, who received the drug Kolofort in monotherapy for 12 weeks, 2 tablets twice a day. To assess the presence and severity of symptoms of functional gastrointestinal disorders (FGID), the “7*7” questionnaire developed by a working group from the Russian Gastroenterological Association was used. The evaluated parameters included the proportion of patients: who had a 50% or more reduction in the total score; who have switched to the less severe category of the condition; who have switched to the “healthy” or “borderline ill” severity categories; and the change in the score in domains 1–7.ResultsThe final efficacy analysis included data from 9254 patients. A decrease in the total score by 50% or more was observed in 80.45% of patients with FD, 79.02% of patients with IBS, and in 83% of patients with both IBS and FD. Switch to a lower severity category of the condition at the end of therapy was noted in 93.35% of patients with FD, in 93.80% of cases in patients with IBS, and in 96.17% of cases in patients with a combination of IBS and FD. A total of 94 adverse events (AEs) were reported in 80 patients (0.65%).ConclusionThe COMFORT program has demonstrated the positive effect of treatment in the majority of patients with IBS and FD and their combination in real clinical practice.

2016-01-01·Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova

Farmacological effects of anti-S100 in release-active form and mechanisms of their realisation

Review

作者: Voronina, T A ; Epshtein, O I ; Khakimova, G R ; Dugina, Yu L ; Ertuzun, I A

Antibodies to 5100 proteins (anti-5100) in release-active form (RA anti-5100) are an active component of some domestic drugs(tenoten, tenoten for children, divaza, brizantin, kolofort and proproten-100). The authors present the results of preclinical and clinical trials (with detailed consideration of experimental data) which demonstrated a wide spectrum of specific pharmacological activity and safety as well as mechanisms of anti-5100 action.

Terapevticheskii arkhiv4区 · 医学

Efficacy of Kolofort for the treatment of patients with irritable bowel syndrome

4区 · 医学

ArticleOA

作者: Tonkih, Ju L ; Vasjutin, A V ; Tsukanov, V V ; Dunaevskaja, O V ; Rzhavicheva, O S ; Bronnikova, E P

Aim. To determine the efficacy and safety of Kolofort in the treatment of patients with irritable bowel syndrome (IBS). Subjects and methods. 52 patients (16 men and 36 women) aged 26 to 59 years were examined over 4 months to rule out organic disease. The diagnosis of IBS was established on the basis of the Rome III diagnostic criteria (2006). Seven patients were diagnosed as having IBS with a preponderance of constipation; 3 had IBS with a preponderance of diarrhea, and 42 had mixed IBS. Thereafter they were given Kolofort, a combination release-active antibody drug having anxiolytic, anti-inflammatory, and spasmolytic effects. Kolofort affects the ligand-receptor interactions of the brain-specific protein S-100 with serotonin receptors and σ1-receptors in the central nervous system and that of histamine with histamine H4 receptors in the gastrointestinal tract and modifies (regulates) the functional activity of tumor necrosis factor-α (TNF-α). The regulatory action of the drug at the level of the central and autonomic nervous system and the immune system manifests itself as spasmolytic, anti-inflammatory, and sedative effects, which as a whole effectively normalizes gastrointestinal motility. For 3 months, the patients took sublingual Kolofort in a dose of 2 tablets thrice daily for 2 weeks, then 2 tablets twice daily for 2.5 months. Control was made 2 weeks, 1, 2, and 3 months after treatment initiation. The investigators assessed abdominal pain syndrome, defecation disorders, abdominal distension, and flatulence by the visual analogue scale (VAS-IBS questionnaire), visceral sensitivity index (VSI questionnaire), quality of life (QL) in patients with IBS (IBS-QoL questionnaire), and stool form according to the Bristol Stool Chart and measured the levels of TNF-α and interleukin (IL)-1β and IL-10 before and after treatment. Results. The efficacy of Kolofort showed itself within 2 weeks of its administration against all the study functional parameters (pain, defecation disorder, and flatulence). After one month of therapy, the efficacy of Kolofort achieved meaningful statistical significance against abdominal pain, complaints of flatulence, visceral sensitivity index, and QL. The statistically significant restoration of a stool form was achieved 2 months after treatment and 3-month Kolofort treatment showed a clear-cut positive clinical effect that appeared as reductions in pain syndrome (214±0.22; р < 0.001) and visceral hypersensitivity symptoms (from 30.33±2.9 to 67.76±6.5; р < 0.001), improvements in subjective sensations associated with defecation disorders (from 6.95±0.71 to 2.74±0.28; р < 0.001), stool form, and QL indicators (from 103.48±9.06 to 44.95±5.4; р < 0.001), and a decrease in blood TNF-α levels after treatment termination (from 9.16 to 7.02 pg/ml; р < 0.026). A Kolofort treatment cycle for IBS produced no clinically relevant side effects. Conclusion. Kolofort was highly effective in relieving symptoms, in normalizing the psychological status, and in lowering the levels of TNF-α in the treatment of IBS. The efficacy of the drug was achieved because of its combined effect on the main components of the pathogenesis of IBS.

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适应症	国家/地区	公司	日期
肠易激综合征	俄罗斯	Materia Medica Holding Research And Production Company	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03119766 (CTgov)	临床4期	消化不良	370	Kolofort (Kolofort)	顧網顧膚範簾網淵選觸(淵壓網餘糧襯觸廠鹹糧) = 膚廠顧遞範餘夢鹹糧夢鏇積願鏇網衊壓積觸鏇 (膚淵願壓繭壓窪糧淵醖, 獵鹹觸齋網遞鏇襯膚壓 ~ 簾願鬱獵廠鹽築蓋衊選) 更多	-	2022-06-07
				Placebo (Placebo)	顧網顧膚範簾網淵選觸(淵壓網餘糧襯觸廠鹹糧) = 鑰顧衊積鬱鬱衊衊遞窪鏇積願鏇網衊壓積觸鏇 (膚淵願壓繭壓窪糧淵醖, 範憲鹽觸積鹹積廠願構 ~ 網壓鹽糧鹽願膚鏇蓋顧) 更多