[Translation] Bioequivalence study of famotidine tablets (20 mg) (test formulation) and Astellas Pharma's Famotidine Tablets (20 mg) (reference formulation) under fed conditions.

主要目的：通过比较餐后条件健康成年人受试者单剂量口服上海世康特制药有限公司生产的法莫替丁片（20mg）（受试制剂）与Astellas Pharma的高舒达（法莫替丁片，20mg）（参比制剂）的吸收速度与吸收程度，来评价两者生物等效性。次要目的：通过临床生物化学、体检和不良事件/严重不良事件监测，来监测参与研究的受试者用药安全性。

[Translation]

The primary objective is to evaluate the bioequivalence of famotidine tablets (20 mg) produced by Shanghai Shikangte Pharmaceutical Co., Ltd. (test preparation) and Astellas Pharma's Famotidine Tablets (20 mg) (reference preparation) after a single oral dose in healthy adult subjects under fed conditions. The secondary objective is to monitor the drug safety of the subjects participating in the study through clinical biochemistry, physical examination and adverse event/serious adverse event monitoring.

Start Date25 Mar 2019

Sponsor / Collaborator

Shanghai Shikangte Pharmaceutical Co.,Ltd.

CTR20191747 / Completed

法莫替丁片（20mg）（受试制剂）与Astellas Pharma的高舒达（法莫替丁片，20mg）（参比制剂）空腹条件下的生物等效性试验。

[Translation] Bioequivalence study of famotidine tablets (20 mg) (test product) and Astellas Pharma's Famotidine Tablets (20 mg) (reference product) under fasting conditions.

主要目的：通过比较空腹条件健康成年人受试者单剂量口服上海世康特制药有限公司生产的法莫替丁片（20mg）（受试制剂）与Astellas Pharma的高舒达（法莫替丁片，20mg）（参比制剂）的吸收速度与吸收程度，来评价两者生物等效性。次要目的：通过临床生物化学、体检和不良事件/严重不良事件监测，来监测参与研究的受试者用药安全性。

[Translation]

The primary objective is to evaluate the bioequivalence of famotidine tablets (20 mg) produced by Shanghai Shikangte Pharmaceutical Co., Ltd. (test preparation) and Astellas Pharma's Famotidine Tablets (20 mg) (reference preparation) after a single oral dose in healthy adult subjects under fasting conditions. The secondary objective is to monitor the drug safety of the subjects participating in the study through clinical biochemistry, physical examination and adverse event/serious adverse event monitoring.

Start Date05 Mar 2019

Sponsor / Collaborator

Shanghai Shikangte Pharmaceutical Co.,Ltd.

100 Clinical Results associated with Hemorrhagic gastritis

100 Translational Medicine associated with Hemorrhagic gastritis

0 Patents (Medical) associated with Hemorrhagic gastritis

419

Literatures (Medical) associated with Hemorrhagic gastritis

09 Jun 2024·Cureus

Racial Differences in Non-variceal Upper Gastrointestinal (GI) Bleeding: A Nationwide Study

Article

Author: Amakye, Dominic ; Obi, Emeka S ; Olaosebikan, Kikelomo ; Ugwu, Chidiebube ; Soladoye, Elizabeth ; Forlemu, Arnold N ; Nana Sede Mbakop, Raissa

Background and aims Knowledge about the impact of race on non-variceal upper GI bleeding (NVUGIB) is limited. This study explored the racial differences in the etiology and outcome of NVUGIB. Methods We conducted a study from 2009 to 2014 using the Nationwide Inpatient Sample (NIS) database. NIS is the largest publicly available all-payer inpatient database in the USA with more than seven million hospital stays each year. The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for NVUGIB, esophagogastroduodenoscopy (EGD) and demographics were obtained. The outcomes of interest were in-hospital mortality, hospital length of stay (HLOS), total hospital charges, admission to the intensive care unit (ICU), and patient disposition. Analysis was conducted using Chi-square tests and Tukey multiple comparisons between groups. Results Among 1,082,516 patients with NVUGIB, African American and Native Americans had the highest proportions of hemorrhagic gastritis/duodenitis (8.2% and 4.2%, respectively) and Mallory-Weiss bleeding (10.4% and 5.4%, respectively; p<0.01). African Americans were less likely to get an EGD done within 24 hours of admission compared to Whites and Latinxs (45.9% vs 50.1% and 50.4%, respectively; p<0.001). In-hospital mortality was similar among African Americans, Latinxs, and Whites (5.8% vs 5.6% vs 5.9%, respectively; p=0.175). Asian/Pacific Islanders and African Americans were more likely to be admitted to the ICU (9.6% and 9.0%, respectively; p<0.001). Moreover, African Americans had a longer HLOS compared to Latinxs and Whites (7.5 vs 6.5 and 6.4 days, respectively; p<0.001). Conversely, Asian/Pacific Islanders and Latinx incurred the highest hospital total charges compared to African Americans and Whites ($81,821 and $69,267 vs $61,484 and $53,767, respectively; p<0.001). Conclusion African Americans are less likely to receive EGD within 24 hours of admission and are more likely to be admitted to the ICU with prolonged hospital lengths of stay. Latinxs are more likely to be uninsured and incur the highest hospital costs.

01 Apr 2023·Clinical Journal of Gastroenterology

Clinical course and treatment of radiation-induced hemorrhagic gastritis: a case series study

Article

Author: Fujisaki, Junko ; Suzuki, Keita ; Yoshimizu, Shoichi ; Horiuchi, Yusuke ; Yoshioka, Yasuo ; Taguchi, Senzo ; Hirasawa, Toshiaki ; Ishiyama, Akiyoshi ; Ikenoyama, Yohei ; Yoshio, Toshiyuki

Radiation-induced hemorrhagic gastritis is a relatively uncommon complication of irradiation that can be severe. However, appropriate treatment guidelines have not yet been established because of the small number of known cases. At our hospital, we encountered nine cases of radiation-induced hemorrhagic gastritis between July 2005 and July 2018. All patients initially underwent argon plasma coagulation (APC) for hemostasis. The treatment was highly effective, and hemostasis was successfully achieved in eight of the cases. Hemostasis could not be achieved in one case treated with APC; therefore, surgical resection was required. This patient had risk factors, such as liver cirrhosis and a history of abdominal surgery. Our case series suggests that APC is an effective hemostatic method that should be considered as the initial treatment option for radiation-induced hemorrhagic gastritis; however, surgical resection may be considered when the patient is at high risk for rebleeding.

01 Dec 2022·TrialsQ4 · MEDICINE

Stop of proton-pump inhibitor treatment in patients with liver cirrhosis (STOPPIT): study protocol for a prospective, multicentre, controlled, randomized, double-blind trial

Q4 · MEDICINE

ArticleOA

Author: Lohse, Ansgar W. ; Krause, Linda ; Wehmeyer, Malte H. ; the STOPPIT-trial group ; Horvatits, Thomas ; Walter, Sarah ; Kluwe, Johannes ; Zapf, Antonia ; Buchholz, Anika

AbstractBackgroundProton-pump inhibitors (PPI) are liberally prescribed in patients with liver cirrhosis. Observational studies link PPI therapy in cirrhotic patients with an increased risk for infectious complications, hepatic encephalopathy and an increased risk for hospitalization and mortality. However, patients with liver cirrhosis are also considered to be at risk for peptic ulcer bleeding. The STOPPIT trial evaluates if discontinuation of a pre-existing PPI treatment delays a composite endpoint of re-hospitalization and/or death in patients (recently) hospitalized with liver cirrhosis compared to patients on continued PPI medication.MethodsThe STOPPIT-trial is a prospective, multicentre, randomized, double-blinded, placebo-controlled, parallel-group trial. In total, 476 patients with complicated liver cirrhosis who already receive long-term PPI therapy without evidence-based indication are 1:1 randomized to receive either esomeprazole 20 mg (control group) or placebo (intervention group) for 360 days. Patients with an indication for PPI therapy (such as a recent diagnosis of peptic ulcers, severe reflux esophagitis, severe hemorrhagic gastritis, recent endoscopic therapy for oesophageal varices) are excluded. The primary composite endpoint is the time-to re-hospitalization and/or death. Secondary endpoints include rates of re-hospitalization, mortality, occurrence of infections, hepatic decompensation and acute-on-chronic liver failure. The safety endpoint is defined as manifestation of an evidence-based indication for PPI re-therapy. The impact of PPI continuation or discontinuation on the intestinal microbiota will be studied. The recruitment will take place at 18 study sites throughout Germany. Recruitment has started in April 2021.DiscussionThe STOPPIT trial is the first clinical trial to study the effects of PPI withdrawal on relevant outcome variables in patients with complicated liver cirrhosis. If the hypothesis that PPI withdrawal improves clinical outcomes of cirrhosis patients is confirmed, this would argue for a strong restriction of the currently liberal prescription practice of PPIs in this population. If, on the other hand, the trial demonstrates an increased risk of gastrointestinal bleeding events in patients after PPI withdrawal, this could create a rationale for a more liberal, prophylactic PPI treatment in patients with liver cirrhosis.Trial registrationEU clinical trials register EudraCT 2019-005008-16 (registered December 27, 2019). ClinicalTrials.gov NCT04448028 (registered June 25, 2020). German Clinical Trials Register DRKS00021290 (registered March 10, 2021).

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