Impact of Peroral Endoscopic Myotomy and Other Treatments for Oesophageal Motility Disorders on Bolus Transport and Gastro-oesophageal Reflux. The pFlow Study
Pressure and flow (PF) analysis allow a detailed report on the bolus passing for each segment of the esophagus. This approach has evidence in oropharyngeal dysphagia, post reflux surgery dysphagia, gastroesophageal reflux in infants and dysphagia in patients with normal manometry. However, it has not been used for defined esophageal motility disorders and their response to surgical or endoscopic treatments. Better knowledge about pre and postoperative bolus flow can yield important concepts that can modify the selection of optimal treatments.
NCT03904004 — Esophageal Motility Disorders
Status: Not yet recruiting
http://inclinicaltrials.com/esophageal-motility-disorders/NCT03904004/
A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease
The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
NCT03736369 — Erosive Esophagitis
Status: Completed
http://inclinicaltrials.com/erosive-esophagitis/NCT03736369/
Clinico-functional Evaluation of Gastroesophageal Reflux Disease (GERD): A Comparative Study Between the Vertical Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Techniques
The hypothesis of this study is that surgical techniques primarily designed for weight loss, ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients. Therefore the present study intends to evaluate such impact on patients submitted to two of the most common techniques available, the Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy.
NCT03692455 — Morbid Obesity
Status: Completed
http://inclinicaltrials.com/morbid-obesity/NCT03692455/
The Effectiveness of Compression and Early Glue Ablation of Saphenous Vein Reflux Compared With Compression Alone in the Healing of Venous Ulcer, a Randomized Controlled Trial
The study evaluates the effects of early endovenous glue ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomized to receive early endovenous ablation (within 2 weeks) and a half to standard care
NCT03666754 — Venous Leg Ulcer
Status: Recruiting
http://inclinicaltrials.com/venous-leg-ulcer/NCT03666754/
Comparison of Treatment Effectiveness and Evaluation of Cost Between Surgical and Non-surgical Treatment for Gastroesophageal Reflux Disease (GERD)
This study was designed to evaluate the effectiveness of laparoscopic antireflux surgery for treatment of gastroesophageal reflux disease (GERD) comparing with that of non-surgical treatment.
NCT03661151 — Gastroesophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux/NCT03661151/
Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH < 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option. Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.
NCT03596476 — Gastro-esophageal Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/gastro-esophageal-reflux-disease/NCT03596476/
Randomized Two-dimensional Between-patient Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose of Osteopathic Manual Therapy in Treatment of Gastroesophageal Reflux Disease
Response Surface Pathway (RSP) design was previously developed for dose-finding studies with one interventional and one response variable, but RSP to higher dimensions is requested. The aim of this study is to introduce and evaluate the RSP design with two interventional and one response variable exemplified by estimating Minimum Efficacy Dose (MED) of Osteopathic Manual Therapy (OMT) in treatment of gastroesophageal reflux disease (GERD).
NCT03568825 — GERD
Status: Completed
http://inclinicaltrials.com/gerd/NCT03568825/
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.
NCT03561883 — Gastroesophageal Reflux Disease (GERD)
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease-gerd/NCT03561883/
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.
NCT03561090 — Gastroesophageal Reflux Disease (GERD)
Status: Terminated
http://inclinicaltrials.com/gastroesophageal-reflux-disease-gerd/NCT03561090/
An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin
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
NCT03553563 — Gastric Ulcer
Status: Completed
http://inclinicaltrials.com/gastric-ulcer/NCT03553563/