A prospective multi-centric, randomised, double-dummy, double- blind, placebo-controlled 3-way Phase III study to investigate the efficacy and safety of two dexamfetamine sulfate formulations in adults with ADHD - DEXINA - - 6520-9970-08

Start Date21 Jun 2024

Sponsor / Collaborator

MEDICE Arzneimittel Pütter GmbH & Co. KG

EUCTR2018-003619-23-DE / Not yet recruitingPhase 4

EFFICACY AND SAFETY OF A PARENTERALLY ADMINISTERED FIXED VITAMIN COMBINATION (VITAMIN B6, B12 AND FOLIC ACID) ON VITAMIN B12 STATUS AND METHYLATION CAPACITY IN COBALAMIN DEFICIENCY COMPARED TO ORAL VITAMIN B12 SUPPLEMENTATION - EASYVit

Start Date29 Nov 2019

Sponsor / Collaborator

MEDICE Arzneimittel Pütter GmbH & Co. KG

CTR20180056 / CompletedPhase 3

评估盐酸哌甲酯缓释胶囊注意缺陷多动障碍患者中的疗效和安全性的安慰剂对照、双盲、多中心研究

[Translation] A placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of methylphenidate hydrochloride extended-release capsules in patients with attention deficit hyperactivity disorder

主要目的：根据4周稳定剂量治疗后ADHD-IV父母评定量表总评分相对基线期的变化，证明个体化滴定剂量的MPH HCl缓释胶囊 (Medikinet® retard)在治疗中国儿童和青少年（6至<18岁）ADHD患者方面相对于安慰剂的优效性。次要目的：研究Medikinet® retard对比安慰剂治疗中国儿童和青少年ADHD患者的安全性。研究给予 10 mg、20 mg 或 30 mg Medikinet® retard 后，MPH HCl在中国儿童和青少年中的 PK。

[Translation]

Primary Objective: To demonstrate the superiority of individually titrated doses of MPH HCl extended-release capsules (Medikinet® retard) over placebo in the treatment of Chinese children and adolescents (6 to <18 years old) with ADHD based on the change from baseline in the ADHD-IV Parent Rating Scale total score after 4 weeks of stable dose treatment. Secondary Objectives: To investigate the safety of Medikinet® retard versus placebo in the treatment of Chinese children and adolescents with ADHD. To investigate the PK of MPH HCl in Chinese children and adolescents after administration of 10 mg, 20 mg, or 30 mg Medikinet® retard.

Start Date22 Sep 2018

Sponsor / Collaborator

Beijing Willingjet Science Co., Ltd.

[+1]

100 Clinical Results associated with MEDICE Arzneimittel Pütter GmbH & Co. KG

0 Patents (Medical) associated with MEDICE Arzneimittel Pütter GmbH & Co. KG

Literatures (Medical) associated with MEDICE Arzneimittel Pütter GmbH & Co. KG

13 Sep 2023·Probiotics and antimicrobial proteins

An 8-Week Course of Bifidobacterium longum 35624^® Is Associated with a Reduction in the Symptoms of Irritable Bowel Syndrome.

Article

Author: Lenoir, Marion ; Roese, Nadine ; Wienke, Jörg ; Fardao-Beyler, Frédérique

Irritable bowel syndrome (IBS) is one of the disorders most frequently diagnosed by gastroenterologists. Probiotics are promising tools for the management of IBS. The objective of the present study was to evaluate the effectiveness and tolerability of a probiotic (Bifidobacterium longum 35624^®) in adults (aged 18 or over) with IBS (as defined by the Rome IV criteria). In an open-label, observational, post-market study conducted in Germany, adults with IBS and a prior recommendation for the intake of B. longum 35624^® were recruited by family physicians. During the 8-week course of treatment, the study participants filled out a weekly questionnaire that enabled calculation of a total IBS symptom score (TISS, the sum of abdominal pain, bloating, passage of gas, constipation, and diarrhea individual symptom scores) and the well-known IBS severity scoring system (IBS-SSS) score. Thirty-seven patients were included. The course of B. longum 35624^® was associated with a significant reduction (43.4%) in the TISS vs. baseline. The mean individual symptom grades for passage of gas and bloating fell significantly from "moderate" at baseline to "very mild to mild" after 8 weeks of treatment, whereas those for abdominal pain and diarrhea fell significantly from "mild to moderate" to "very mild to mild." Over 60% of the participants achieved clinically meaningful reductions in the TISS (> 30%) and the IBS-SSS score (> 50 points). The effectiveness of B. longum 35624^® was rated as "good to satisfactory" by study participants and the investigating physicians. One mild adverse event (nausea) was potentially linked to the study treatment. We conclude that an 8-week course of B. longum 35624^® was associated with significant, clinically meaningful symptom relief in a typical population of adult patients with IBS.

01 May 2023·Natural Product Communications

Antidiarrheal Properties of the Combination of Tannin Albuminate and Ethacridine Lactate - A Narrative Review

Author: Roese, Nadine ; Salama-Müller, Andera

Objective To review the efficacy and safety of tannin albuminate and ethacridine lactate monohydrate in the treatment and prevention of diarrhea. Design Narrative review. Data sources: A systematic literature search was conducted in MEDLINE and Embase from inception to September 2022. The search was restricted to English and German language publications. Eligibility criteria for selecting studies: Randomized controlled trials, non-interventional studies, and meta-analyses assessing tannin and/or ethacridine for the treatment or prevention of diarrhea. Results Of 366 titles identified, a total of 13 studies were included in this review. Five randomized controlled trials and four noninterventional trials demonstrate the efficacy and safety of the fixed combination of tannin albuminate and ethacridine lactate monohydrate in treating acute diarrhea and preventing traveler's diarrhea. The fixed combination reduced acute diarrhea duration by improving stool frequency, consistency, and weight and reduced the risk of traveler's diarrhea. Two pilot studies indicate efficacy in chronic diarrhea. Safety and tolerability were very good in all included studies. Two meta-analyses investigated the efficacy of gelatin tannate in children with acute gastroenteritis. Conclusion The efficacy and safety of tannin albuminate and ethacridine lactate monohydrate for the treatment of acute diarrhea and the prevention of traveler's diarrhea are proven in randomized controlled trials. Several noninterventional studies substantiate the real-world effectiveness and tolerability of the fixed combination. Both active ingredients combine antidiarrheal, antimicrobial, mucosal protection, and spasmolytic properties. However, existing clinical data should be updated with larger, well-designed, placebo-controlled trials in adult and pediatric patient populations.

01 Jan 2023·Scandinavian Journal of Child and Adolescent Psychiatry and Psychology

Pharmacokinetics of a Modified-Release Dexamphetamine Sulfate Formulation Following Single and Multiple Dosing in Healthy Adults: Comparative Bioavailability with Immediate-Release Dexamphetamine Sulfate, between Strengths, Assessment of Food and Meal Composition Effects

Article

Author: Sandersleben, Henrik Uebel-von ; Dangel, Oliver ; Mayer, Anke ; Ruhmann, Michaela ; Schütz, Helmut

AbstractBackgroundA modified-release dexamphetamine sulfate formulation (DEX-MR) is under development for the treatment of attention-deficit/hyperactivity disorder.ObjectiveWe investigated the bioequivalence of once-daily DEX-MR to twice-daily immediate-release dexamphetamine sulfate (DEX-IR) after single and multiple dosing and between strengths, and effects of food and meal types.MethodThree randomized, open-label, crossover studies in healthy males were conducted. In the single-dose study, participants received DEX-MR 20 mg, DEX-MR 10 mg (20 mg dose), and twice-daily DEX-IR 10 mg under fasted conditions and after a high-fat, high-calorie breakfast. In the breakfast study, participants received DEX-MR 20 mg and twice-daily DEX-IR 10 mg after a normocaloric and a high-fat, high-calorie breakfast. In the multiple-dose study, participants received DEX-MR 20 mg and twice-daily DEX-IR 10 mg for seven days each. In the run-in period (five days), participants consumed a normocaloric breakfast; on profile days, participants consumed a normocaloric breakfast (day 6) or a high-fat, high-calorie breakfast (day 7).ResultsOnce-daily DEX-MR at a dose of 20 mg was bioequivalent to twice-daily DEX-IR 10 mg after single dosing under fasted and fed conditions and after multiple dosing under fed conditions. DEX-MR 10 mg and DEX-MR 20 mg were bioequivalent when administered as a single 20 mg dose. Food slightly reduced the rate and extent of absorption of DEX-MR and delayed the time to peak plasma concentration (tmax) by approximately two hours compared to the fasted state. Bioavailability of DEX-MR was comparable under different meal conditions (normocaloric vs. high-fat, high-calorie breakfast) both after single and multiple dosing.ConclusionsBioequivalence of once-daily DEX-MR and twice-daily DEX-IR was established. 1×2 DEX-MR 10 mg was bioequivalent to 1×1 DEX-MR 20 mg. DEX-MR should be administered with/after a meal to achieve the targeted pharmacokinetic profile (delayed tmax). Bioavailability of DEX-MR is not affected by meal composition (i.e., fat and caloric content).

100 Deals associated with MEDICE Arzneimittel Pütter GmbH & Co. KG

100 Translational Medicine associated with MEDICE Arzneimittel Pütter GmbH & Co. KG

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