Clinical Trials Logo
  1. Home
  2. Gastroesophageal Reflux Disease
  3. NCT02096458

Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

Gastroesophageal Reflux Disease Clinical Trial

Official title:
An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107

Clinical Trial Summary

The purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.

Clinical Trial Description

The drug being tested in this study is called dexlansoprazole. An orally disintegrating (OD) form of dexlansoprazole is being tested to look at the average time that it takes for one tablet to disintegrate in the mouth of healthy volunteers. At the point at which the panelist would normally swallow the granules, they will record the time and expectorate the disintegrated tablet mass and not actually swallow the tablet or granules.

The study will enroll approximately 8 healthy volunteers. All participants will take one dexlansoprazole 30 mg OD tablet on up to three separate study days. No more than 60 mg of dexlansoprazole will be tested in any one day.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is approximately 2 weeks. Participants will make up to 4 visits to the clinic, and will be contacted by telephone approximately 1 week after last dose of study drug for a follow-up assessment. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02096458
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date February 2014
Completion date February 2014
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 NCT01200550 - The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients 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 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 NCT00768196 - Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients N/A
Completed NCT00768443 - Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD) 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 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 NCT00214552 - Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma. Phase 3
Completed NCT00618150 - Patient Education in Gastroesophageal Reflux Disease N/A
Completed NCT03299985 - Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease N/A