Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.

Clinical Trial Description

The drug being tested in this study is called dexlansoprazole. A dual delayed release formulation of dexlansoprazole, referred to as dexlansoprazole modified release (dexlansoprazole MR) was tested to treat people who have gastroesophageal reflux disease (GERD). This study looked at the healing of the esophageal lining of the GERD participants who took dexlansoprazole MR.

The study enrolled 296 patients. Participants were assigned to two study groups based on the endoscopy screening procedures to receive treatments as follows:

- Dexlansoprazole 30 mg to participants with non-erosive reflux disease (NERD)

- Dexlansoprazole 60 mg to participants with erosive esophagitis (EE)

All participants were asked to take one capsule in the morning each day throughout the study. All participants were asked to record the presence and maximum severity of daytime and nighttime heartburn and regurgitation symptoms during screening and, if assigned to a treatment group, throughout the duration of the study using the supplied paper diary.

This multi-center trial was conducted in Asia (Hong Kong, Taiwan, South Korea). The overall time to participate in this study was up to 8 weeks. Participants would make up to 3 visits to the clinic, and would be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02351960
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 4
Start date	March 19, 2015
Completion date	July 13, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02135107` - A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients	Phase 3
Completed	`NCT01432392` - Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease	N/A
Recruiting	`NCT01249482` - Symptom Assessment for GERD Patients Receiving H. Pylori Eradication	N/A
Completed	`NCT01578642` - Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease	Phase 2
Completed	`NCT01200550` - The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients	N/A
Completed	`NCT00978016` - A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)	Phase 2
Unknown status	`NCT01128608` - The Effect of High PCO2 Solution on Esophageal Acid Sensation	N/A
Completed	`NCT00998244` - Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease	N/A
Completed	`NCT00768443` - Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)	N/A
Completed	`NCT00768196` - Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients	N/A
Recruiting	`NCT00498082` - Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease	N/A
Completed	`NCT00886197` - Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease	N/A
Completed	`NCT00378898` - Feasibility of Placing Bravo PH Capsule in Proximal Esophagus	N/A
Completed	`NCT00507377` - Foreshortened Esophagus and Its Surgical Therapy
Completed	`NCT00217347` - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy	N/A
Completed	`NCT00165022` - Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population	N/A
Completed	`NCT00214552` - Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.	Phase 3
Completed	`NCT00625495` - Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)	Phase 4
Completed	`NCT00618150` - Patient Education in Gastroesophageal Reflux Disease	N/A
Completed	`NCT03299985` - Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease	N/A