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Proton Pump Inhibitor clinical trials

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NCT ID: NCT05647278 Active, not recruiting - Clinical trials for Helicobacter Pylori Infection

A RCT of the Efficacy of Tegoprazan 50mg QD in the Treatment of Helicobacter Pylori Infection ( TATH-1 )

TATH-1
Start date: November 1, 2022
Phase: Phase 4
Study type: Interventional

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of Tegoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, some studies use Tegoprazan instead of common proton pump inhibitor, but almost all use double dose of Tegoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 50mg QD of Tegoprazan. Therefore, in this study, 50mg QD of Tegoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of Tegoprazan on Helicobacter pylori.

NCT ID: NCT05590286 Recruiting - Clinical trials for Helicobacter Pylori Infection

A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

VATH-1
Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

The treatment of helicobacter pylori is very important. The routine treatment is quadruple therapy. In recent years, double therapy has appeared and the curative effect is fair. However, antacid generally uses proton pump inhibitor. The proton pump inhibitor needs double dose to achieve good antacid curative effect. The effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. At present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. In the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg QD of vonoprazan. Therefore, in this study, 20mg QD of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on Helicobacter pylori.

NCT ID: NCT05533619 Completed - Acute Kidney Injury Clinical Trials

Risk Factors and Machine Learning Model for Proton Pump Inhibitor Related Acute Kidney Injury

Start date: July 1, 2022
Phase:
Study type: Observational

Recent evidence concerns acute kidney injury (AKI) following proton pump inhibitor (PPI) application. Few actual studies have compared the incidence, risk factors, and predictive models of AKI associated with PPI. The present study was a single-center retrospective study. The researchers retrospectively analyzed data from patients who received PPI medications between January 2018 and December 2020. PPI drugs included omeprazole, esomeprazole, rabeprazole, and pantoprazole. The primary outcome of the study was AKI, as defined by kidney disease: improving global outcomes (KDIGO). Secondary outcomes included length of hospital stay, hospital costs, and continuous renal replacement therapy. Independent risk factors associated with AKI were identified by univariate analysis and multifactorial logistic regression analysis (P < 0.05). Logistic regression models were constructed based on the variables obtained from the analysis. Internal validation of the model was performed by the ten-fold cross-validation method. Model discriminatory power was assessed by the area under the curve (AUC) of the receiver operating characteristic curve (ROC). The study aims to develop a PPI-related AKI prediction model based on an electronic medical record system that can be used to predict AKI in hospitalized patients and contribute to the early prevention, diagnosis and treatment of AKI, ultimately reducing morbidity and improving prognosis.

NCT ID: NCT05348252 Completed - Clinical trials for Proton Pump Inhibitor

Patient Journey Application for Discontinuing Inappropriate PPI Use: a Randomized Controlled Trial

SUPPORT
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Rationale/objective: This study hypothesizes that offering patient-tailored and dosed information on PPI discontinuation in patients with inappropriate chronic PPI use will result in an increased discontinuation rate when compared to a conventional information folder offering all information on discontinuing inappropriate PPI use at once. Study design: Multicenter randomized controlled trial. Study population: A minimum 152 patients with chronic PPI use without a valid indication for chronic PPI use according to the NHG-guidelines will be included. Possible participants will be identified at the outpatient clinics of the departments of Internal Medicine, Gastroenterology, Rheumatology and Nephrology in the Radboud University Medical Center, Canisius Wilhelmina Hospital and Sint Maartenskliniek. Intervention: Timely informing patients on discontinuing PPI use through the Patient Journey App. Control: Conventional information, consisting of an online information folder on discontinuing PPI use. Inclusion criteria: - Patients with daily PPI use for at least 4 weeks; - Age 18-70 years. Exclusion criteria: - Chronic PPI indication according to NHG-guidelines; - Chronic PPI indication according to treating physician, despite absence of chronic PPI indication according to NHG-guidelines; - Patients that underwent anti-reflux surgery; - No understanding of the study or study procedures including the digital application (smartphone/computer skills); - No smartphone/computer available; - No informed consent; - Limited life span. Primary end point: - Discontinuation of PPI use at 2-month follow-up, defined as self-declared intake of a maximum of 1 tablet in the previous 14 days. Secondary end points: - Upper gastrointestinal symptoms or disorders that are potentially related to discontinuation of PPI use, subdivided as: - Upper gastrointestinal symptoms as measured by the Patient Assessment of Gastrointestinal Symptom Severity Score (PAGI-SYM); - Any upper gastrointestinal event that requires a doctor's visit or hospitalization. - Potential adverse drug reactions (ADRs) of PPIs, subdivided as: - Most prevalent (1-10%) ADRs according to the Medicines Evaluation Board1: obstipation, diarrhea, meteorism, abdominal pain, nausea/vomitus, headache; - Other potential ADRs requiring a doctor's visit or hospitalization. The following disorders are considered as potentially related to PPI use: any pneumonia, gastroenteritis, vitamin B12 deficiency, iron deficiency, calcium deficiency, fractures, acute interstitial nephritis or hypomagnesaemia. - Frequency of PPI use, measured monthly during follow-up, measured as number of PPI tablets per month; - Start of new medication for upper gastrointestinal symptoms, other than PPI (e.g., antacids, H2-blockers, analgesics, anti-emetics); - Association between successful discontinuation and variables such as gender, age, fear of ADRs, occurrence of potential ADRs or occurrence of rebound effect; - Change in lifestyle (BMI, smoking status and alcohol usage); - Patient Journey App usability as measured by the System Usability Score (SUS); - Self-management behavior as measured by the short Patient Activation Measure (PAM-13); - Recurrent PPI use, defined as the intake of more than 1 PPI tablet in the previous 14 days measured as self-declared intake during follow-up after successful discontinuation during follow-up.

NCT ID: NCT04637750 Completed - Primary Care Clinical Trials

Proton Pump Inhibitors (PPI): a Study to Improve Appropriate Prescriptions in the Elderly

LAPTOP-PPI
Start date: October 10, 2019
Phase: N/A
Study type: Interventional

Proton Pump Inhibitors(PPIs) are the leading evidence-based therapy for upper gastrointestinal disorders and prevention of antiplatelet or non-steroidal anti-inflammatory drugs induced ulcer. In Italy in 2015 nearly 3,5 millions of people were treated with PPI. Despite the extensive literature regarding PPI adverse event, their inappropriate prescription rate is still increasing, and Campania and Lombardy region are at the highest level. For this reason a cluster-randomised controlled trial will be performed, in order to evaluate if a low-cost informative intervention addressed to GPs is effective in improving PPIs prescription in older people. The threshold will be defined according to the distribution of the rate of appropriate PPI prescriptions for a 6 months lag time starting 1 year before randomisation (baseline assessment).

NCT ID: NCT04329000 Completed - Barrett Esophagus Clinical Trials

On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

Start date: February 2, 2010
Phase: N/A
Study type: Interventional

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

NCT ID: NCT03980899 Completed - Clinical trials for Proton Pump Inhibitor

Evaluation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication

EGERIPP 2
Start date: July 4, 2019
Phase:
Study type: Observational [Patient Registry]

Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs), prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects, symptomatic treatment of gastroesophageal reflux disease (GERD), esophagitis by GERD, maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome. Several misuse situations had been identified by the High Authority of Health (HAS) in its reassessment in 2009. Although these molecules are very well tolerated in the short term, studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections, Clostridium difficile infections and an increased risk of fractures.

NCT ID: NCT03467893 Completed - Clinical trials for Proton Pump Inhibitor

Evaluation of Rebound Effect After Withdrawal of Proton Pump Inhibitor in Geriatric Population

Start date: June 10, 2017
Phase:
Study type: Observational

Proton pump inhibitor are frequently used and are short term well tolerated ; but few studies show there are adverse event in long term prescription like fracture or pulmonary infection to Clostridum difficile. The fact is that multi medication in old patient increase the iatrogenic risk and decrease the medication compliance. The Proton pump inhibitor (PPI)are overused in this patient category.Several studies suggest the existence of a rebound effect when people were treated more than 8 weeks ; this effect seems to appear around 14 days after with hyperacidity symptoms. But there are no studies about old patient. So in this context the aim of the study is to evaluate the prevalence of rebound effect occurence after the end of PPI 8 weeks treatment.

NCT ID: NCT03098537 Recruiting - Enteral Nutrition Clinical Trials

Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.

NCT ID: NCT03079050 Completed - GERD Clinical Trials

An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan

Start date: February 27, 2017
Phase: Phase 4
Study type: Interventional

Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet needs that may accompany traditional proton pump inhibitors, with two separate pH-depended release phases, the first in the proximal duodenum and the second in the more distal small intestine. This dual release system extends the plasma concentration and pharmacodynamics effects beyond those of single-release PPIs, allowing for dosing at any time of the day without regard to meals 1. A study conducted by Fass et al. has shown that the use of dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and consequently improving work productivity, sleep quality and quality of life 2. Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove beneficial in optimizing the management of GERD and the associated burdens that often surface after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep quality.