Gastroesophageal Reflux Disease Clinical Trial
Official title:
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic
profile and greater overall drug absorption in gastroparesis. This will result in shorter
time to maximal drug concentration, greater maximal concentration, and greater total area
under the curve of the concentration vs. time plot.
Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release
suspension and delayed-release capsules in patients with heartburn associated with
gastroparesis.
Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days
washout. Pharmacokinetic studies will be performed after 7 days on study drug.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
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 |
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 |
NCT00507377 -
Foreshortened Esophagus and Its Surgical Therapy
|
||
| 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 |