A Randomized, Double-Blind, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro-Esophageal Reflux Disease Who have a Partial Response Following Treatment with a High Dose of Proton Pump Inhibitor

开始日期2017-02-08

申办/合作机构

Takeda Development Centre Europe Ltd.

EUCTR2014-005142-21-AT / Not yet recruiting临床2期

A Multicenter, Randomized, Double Blind, Placebo Controlled, Proof of Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Weekly Subcutaneous MLN1202, in Improving Diabetic Nephropathy Subjects with Macroalbuminuria - MLN1202 75, 105, 150 mg as add-on to ACE/ARB to treat Diabetic Nephropathy

开始日期2015-07-21

申办/合作机构

Takeda Development Centre Europe Ltd.

EUCTR2014-005619-18-DE / Not yet recruitingN/A

A Randomized, Open-Label, 2-Way Cross-over, Phase 4 Study to Evaluate Subject Preference and Acceptability of a New Formulation of Calcichew D3 in Adult Patients Eligible for Calcium and Vitamin D Supplementation.

开始日期2015-06-12

申办/合作机构

Takeda Development Centre Europe Ltd.

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项与 Takeda Development Centre Europe Ltd. 相关的文献（医药）

2021-04-01·Gut1区 · 医学

Epidemiology and outcomes of gastroparesis, as documented in general practice records, in the United Kingdom

1区 · 医学

Article

作者: Ford, Alexander C ; Ye, Yizhou ; Jiang, Baoguo ; Moses, Peter L ; Dolin, Paul ; Bennett, Dimitri ; Almansa, Cristina ; Manne, Sudhakar

ObjectiveTo generate real-world evidence for the epidemiology of gastroparesis in the UK, we evaluated the prevalence, incidence, patient characteristics and outcomes of gastroparesis in the Clinical Practice Research Datalink (CPRD) database.DesignThis was a retrospective, cross-sectional study. Prevalence and incidence of gastroparesis were evaluated in the CPRD database, with linkage to Hospital Episodes Statistics Admitted Patient Care and Office for National Statistics mortality data. Prevalence and incidence were age and sex standardised to mid-2017 UK population estimates. Descriptive analyses of demographics, aetiologies, pharmacological therapies and mortality were conducted.ResultsStandardised prevalence of gastroparesis, as documented in general practice records, was 13.8 (95% CI 12.6 to 15.1) per 100 000 persons in 2016, and standardised incidence of gastroparesis rose from 1.5 (95% CI 1.1 to 1.8) per 100 000 person-years in 2004 to 1.9 (95% CI 1.4 to 2.3) per 100 000 person-years in 2016. The most common disease aetiologies were idiopathic (39.4%) and diabetic gastroparesis (37.5%), with a similar distribution of type 1 and type 2 diabetes among the 90% who had type of diabetes documented. Patients with diabetic gastroparesis had a significantly higher risk of mortality than those with idiopathic gastroparesis after diagnosis (adjusted HR 1.9, 95% CI 1.2 to 3.0). Of those with gastroparesis, 31.6% were not offered any recognised pharmacological therapy after diagnosis.ConclusionThis is, to our knowledge, the first population-based study providing data on epidemiology and outcomes of gastroparesis in Europe. Further research is required to fully understand the factors influencing outcomes and survival of patients with gastroparesis.

2020-02-01·Psychopharmacology3区 · 医学

A randomized, placebo-controlled, phase 1 study to evaluate the effects of TAK-063 on ketamine-induced changes in fMRI BOLD signal in healthy subjects

3区 · 医学

Article

作者: Goldsmith, Paul ; Macek, Thomas A ; Renshaw, Perry F ; Yurgelun-Todd, Deborah A ; Uz, Tolga

AbstractRationalePhosphodiesterase 10A inhibitor TAK-063 has shown effects that suggest efficacy in schizophrenia treatment.ObjectiveThis randomized, double-blind, placebo-controlled, incomplete-crossover study investigated effects of single oral administration of TAK-063 on ketamine-induced changes in blood oxygen level-dependent (BOLD) signal in healthy males.MethodsHealthy men aged 18 to 45 years with normal magnetic resonance imaging (MRI) scans and electroencephalogram measurements at screening were eligible. Each subject was randomized to one of nine treatment schedules: all subjects received placebo and two of three doses of TAK-063 followed by ketamine. The primary endpoint was ketamine-induced brain activity in select regions of the brain during resting state. Secondary endpoints included pharmacokinetic parameters of TAK-063, proportion of subjects with treatment-emergent adverse events (AEs), and percentage of subjects meeting criteria for abnormal safety laboratory tests and vital sign measurements.ResultsThe study comprised 27 subjects. Prior to ketamine infusion, TAK-063 exerted region-specific effects on resting state functional MRI (fMRI) BOLD signal. After ketamine administration, TAK-063 reduced the Cohen’s effect size for resting-state fMRI BOLD signal in key brain regions examined, and exerted similar effects on BOLD signal during the working memory task across all doses. TAK-063 was safe and well tolerated.ConclusionsOur results are consistent with non-clinical studies of ketamine and TAK-063 and clinical studies of ketamine and risperidone. It is unknown whether these data are predictive of potential antipsychotic efficacy, and further analyses are required.

2019-12-01·Advances in Therapy3区 · 医学

Prevalence of Anal Fistulas in Europe: Systematic Literature Reviews and Population-Based Database Analysis

3区 · 医学

Review

作者: van Dijk, Marc ; Bennett, Dimitri ; Diez, Mary Carmen ; García-Olmo, Damián ; Van Assche, Gert ; Hokkanen, Suvi R K ; Khalid, Javaria Mona ; Richard, Marie Paule ; Tagarro, Ignacio ; Panés, Julián

INTRODUCTIONDespite the fact that perianal fistulas are associated with significant morbidity and impaired quality of life, their prevalence in Europe is unknown. The aim of this study was to estimate the prevalence of perianal fistulas in Europe, overall and according to etiology.METHODSTwo independent literature reviews were performed using different search strategies to maximize the identification of potentially relevant studies. Data from relevant articles were used to estimate the prevalence of perianal fistulas in Europe. The robustness of the estimate was evaluated using data from a large population-based database from the UK.RESULTSA total of 26 studies provided epidemiological data on perianal fistulas, of which 16 provided suitable data to estimate the prevalence. Estimations using these data yielded a total prevalence of 1.69 per 10,000 population. Cryptoglandular infection and Crohn's disease (CD) were the predominant etiologies, with prevalence rates at 0.86 and 0.76 per 10,000 population, respectively. Comparison of prevalence data from the UK population-based database with the European population resulted in a standardized prevalence estimate of all perianal fistulas of 1.83 per 10,000 population, confirming the robustness of the literature-based estimate.CONCLUSIONAlthough in terms of incidence cryptoglandular fistulas were clearly predominant, the prevalence of fistulas in CD and cryptoglandular infection appeared more balanced. This is due to the longer duration and higher frequency of relapses of fistulas in CD. The estimated prevalence implies that perianal fistulas meet the criteria to be considered as a rare condition in Europe (prevalence less than 5 per 10,000 population).FUNDINGThis study was funded by Takeda Pharmaceutical U.S.A., Inc. and TiGenix SAU.

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100 项与 Takeda Development Centre Europe Ltd. 相关的转化医学

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