Clinical Trials Logo
  1. Home
  2. Gastroesophageal Reflux Disease
  3. NCT00410592
  4. Details
NCT00410592 Clinical Trial

Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

Gastroesophageal Reflux Disease Clinical Trial

Official title:
A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00410592
Other study ID # D9612L00106
Secondary ID
Status Completed
Phase Phase 4
First received December 12, 2006
Last updated March 10, 2009
Start date October 2006
Est. completion date May 2007

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

- Signed informed consent

- Males and females ages 18-69 who are of Hispanic origin

- Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months

Exclusion Criteria:

- Female patients who are pregnant or breastfeeding

- Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix

- Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole 40mg

• Pantoprazole 40mg

• Lansoprazole 30mg

Locations
Country Name City State
Puerto Rico Research Site San Juan
United States Research Site Anaheim California
United States Research SIte Chapel Hill North Carolina
United States Research Site Chicago Illinois
United States Research Site Houston Texas
United States Research Site Miami Florida
United States Research Site Orange California
United States Research Site San Diego California

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.
Secondary Compare nocturnal intragastric pH in Hispanic patients with GERD
Secondary Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
Secondary Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
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 NCT00998244 - Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease 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 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 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