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This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want.
Multispectral imaging represents an exciting new field of investigation in endoscopic research. Multispectral imaging uses a specialised camera to detect multiple colours, allowing us to build a rough spectrum from each point in our image. It is widely reported that these spectra are different for different tissue types, but this is difficult to study ex vivo since de-oxygenation of the blood and decay of the tissue change these spectra considerably. The investigators have therefore designed this study to asses the different multispectral imaging spectra of Barrett's Oesophagus, which we believe might be utilised as a method to detect dysplasia in the future.
The purpose of this study is to evaluate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) when used as maintenance therapy for reflux esophagitis in routine clinical settings.
The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on sleep disturbance of patients with reflux esophagitis, who have heartburn and/or regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the maintenance treatment with PPI other than vonoprazan.
This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.
Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. When compared with the advanced upper third gastric cancer, proximal gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric cancer located in the upper third of the stomach. However, due to abandon the anti-reflux barrier of the digestive system caused by the dissection of the cardia and the lower esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as well as the reflux esophagitis caused by the traditional esophagostomy permanently influence the postoperative quality of life for those patients. Nowadays, relationship between the digestive track reconstruction for proximal gastrectomy and the postoperative quality of life is still with controversies. Previous study reported the gastric tube anastomosis can minimize the reflux related symptoms when compared with traditional esophagogastrostomy. There still exited some patients need long-term anti-acid drug to control the reflux symptoms although underwent the gastric tube anastomosis. The double-track anastomosis for proximal gastrectomy may successfully control the reflux symptoms and there existed study found it is as safe as the esophagostomy. But there has no randomized control study to compare the postoperative quality of life between the gastric tube anastomosis and double-track anastomosis for proximal gastrectomy. By the reasons above, a randomized controlled trial is conducted with the intention to compare the intraoperative and postoperative mortality and morbidity and the postoperative quality of life between the esophagogastrostomy and the double-track anastomosis in the proximal gastrectomy for gastric cancer patients.
The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.
The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.