A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.
NCT04799158 — Heartburn
Status: Completed
http://inclinicaltrials.com/heartburn/NCT04799158/
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
NCT04788485 — Gastroesophageal Reflux in Neonates
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-in-neonates/NCT04788485/
The Effectiveness of Gastroesophageal Reflux Improvement in Different Treatments in Thoracolumbar Kyphotic Patients Who Fulfill the Surgical Indications
The investigator aimed to investigate the gastroesophageal reflux disease (GERD) along with esophageal motility in thoracolumbar kyphotic patients who meet surgical spinal correction criteria. Because some patients refused to receive spinal correction surgery, our patients divided into surgical and non-surgical treatment (for example: brace) groups. The investigator intended to use (1) multichannel intraluminal impedance-pH (MII-pH) monitoring to assess the height, non-acidic and acidic regurgitation of gastroesophageal reflux disease (GERD) (2) high resolution impedance manometry (HRIM) to esophageal motility between pretreatment and posttreatment period. (3) the questionnaire to evaluate the reflux-related symptoms: the frequency scale for the symptoms of GERD (FSSG), gastrointestinal symptom rating scale (GSRS) and Carlsson-Dent self-administered questionnaire (QUEST)
NCT04521985 — the GERD Occurence
Status: Not yet recruiting
http://inclinicaltrials.com/the-gerd-occurence/NCT04521985/
The Effect of an Intestinal Adsorbent on Hydrogen and Methane Breath Testing, in Patients With Abdominal and Reflux Symptoms, on Long Term Proton Pump Inhibitor Therapy
To determine the effect of an intestinal adsorbent on hydrogen and methane breath levels in patients who have been on long term PPI therapy reporting reflux and abdominal symptoms at baseline.
NCT04492839 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT04492839/
Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
The trial would to try to establish: - The best post-operative PPI prescription protocol after Sleeve Gastrectomy - The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett) - The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ
NCT04400136 — Bariatric Surgery Candidate
Status: Not yet recruiting
http://inclinicaltrials.com/bariatric-surgery-candidate/NCT04400136/
A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy of Fosamprenavir/Lexiva for Laryngopharyngeal Reflux (LPR)
Laryngopharyngeal reflux (LPR) causes chronic cough, throat clearing, hoarseness, and dysphagia and if left untreated can promote the development of laryngeal cancer. More than 20% of the United Stated population suffer from LPR, yet there is no effective medical therapy. Proton pump inhibitors (PPIs), which inhibit gastric acid production but do not prevent reflux events, continue to be prescribed for LPR despite their poor efficacy for this patient population, high cost ($26 billion/year), and associated risks. Pepsin, detected in the airway of these patients and now known to cause laryngeal inflammation and promote disease independent of gastric acid, is a key therapeutic target. We report preclinical studies of select HIV inhibitors that bind to and inhibit pepsin and thus hold promise for the treatment of LPR. In support, a very low incidence of LPR was found in patients taking these drugs compared to the general population. HIV inhibitors are ideal drugs to repurpose because they target a foreign virus. Thus, a repurposing approach can be used to safely perform proof of concept testing of the efficacy of a pepsin inhibitor for LPR. The Specific Aim of this project is to perform a 12-week randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of fosamprenavir/Lexiva for LPR. Lexiva will be used at the FDA approved, manufacturers recommended dose for HIV for 12 weeks in medically refractory patients with clinically diagnosed moderate/severe LPR and combined multi-channel intraluminal impedance - pH (MII-pH) confirmed laryngeal reflux events. Routine clinical outcome measures for LPR (Reflux Symptom Index and Reflux Finding Score) will be documented pre- and post-treatment with Lexiva (n = 52) and placebo (n = 52). Saliva will be collected pre- and post-treatment for both pepsin protein analysis and kinetic activity assay to compare with clinical measures. There is currently no effective medical therapy for LPR and pepsin is the key therapeutic target. Identification of an FDA approved drug which inhibits pepsin allows for a clinical trial to determine efficacy using a faster and safer repurposing approach to address a significant gap.
NCT04383262 — Laryngopharyngeal Reflux
Status: Not yet recruiting
http://inclinicaltrials.com/laryngopharyngeal-reflux/NCT04383262/
National, Multicentre, Observational, Non-Interventional Prospective Study of Dexlansoprazole MR in GERD Patients in the Russian Federation
The primary purpose of the study is to evaluate effect of Dexilant treatment among GERD participants in the Russian Federation.
NCT04311541 — Gastroesophageal Reflux Disease
Status: Withdrawn
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT04311541/
A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease
NCT04282954 — GERD
Status: Completed
http://inclinicaltrials.com/gerd/NCT04282954/
Long-term Quality of Life Results After Laparoscopic Fundoplication With and Without Short Gastric Vessel Division in Gastroesophageal Reflux Management
The present study focuses on determining aspects of satisfaction and quality of life of patients that underwent laparoscopic Nissen fundoplication with or without short gastric vessel division (SGVD) and long-term differences.
NCT04237038 — Quality of Life
Status: Completed
http://inclinicaltrials.com/quality-of-life/NCT04237038/
Comparison of Gastroesophageal Reflux Between Conventional Versus Oblique Fibers Sparing Endoscopic Myotomy for Achalasia Cardia - A Randomized Controlled Trial
In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.
NCT04229342 — GERD
Status: Completed
http://inclinicaltrials.com/gerd/NCT04229342/