Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.
Verified date | November 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in
children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis")
caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.
To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the
lining of the food pipe.
To collect information that will describe the psychological, social, and economic effects on
the primary caregiver of raising children ages 1 to 5 years old with GERD.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 11 Years |
Eligibility |
Inclusion Criteria: - Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures. - Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically =6 years of age) must have assent documented by study personnel prior to any study-related procedures. - Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy. Exclusion Criteria: - Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole. - Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization. - Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site | Brussels | |
Belgium | Research Site | Brussels (Jette) | |
Belgium | Research Site | Brussels (Laeken) | |
Belgium | Research Site | Brussels (Woluwé-St-Lambert) | |
Belgium | Research Site | Leuven | |
France | Research Site | Lille | |
France | Research Site | Paris | |
France | Research Site | Tours | |
Italy | Research Site | Genova | GE |
Italy | Research Site | Napoli | |
Italy | Research Site | Parma | PR |
Italy | Research Site | Roma | RM |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Brooklyn | New York |
United States | Research Site | Buffalo | New York |
United States | Research Site | Burlington | Vermont |
United States | Research Site | Chattanooga | Tennessee |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Dallas | Texas |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Hershey | Pennsylvania |
United States | Research Site | Houston | Texas |
United States | Research Site | Jackson | Mississippi |
United States | Research Site | Mobile | Alabama |
United States | Research Site | Morristown | New Jersey |
United States | Research Site | Norfolk | Virginia |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Orlando | Florida |
United States | Research Site | Park Ridge | Illinois |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | St. Louis | Missouri |
United States | Research Site | Troy | Michigan |
United States | Research Site | West Islip | New York |
United States | Research Site | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Belgium, France, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive. | |||
Primary | The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events. | |||
Secondary | The secondary objective of the study is to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive. | |||
Secondary | The secondary objectives include: | |||
Secondary | - Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian. | |||
Secondary | - Assessment of changes from baseline in Physician's Global Assessment | |||
Secondary | - Assessment of endoscopic healing of erosive esophagitis |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03561883 -
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
|
Phase 3 | |
Completed |
NCT01406210 -
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
|
N/A | |
Completed |
NCT02555852 -
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
|
N/A | |
Terminated |
NCT01327963 -
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
|
N/A | |
Completed |
NCT01570842 -
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
|
N/A | |
Completed |
NCT02141711 -
TAK-438 - Safety, Blood Levels & Effects of Repeated Doses
|
Phase 1 | |
Terminated |
NCT00587275 -
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
|
Phase 2 | |
Completed |
NCT00261300 -
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
|
Phase 3 | |
Recruiting |
NCT04506593 -
Indiana University Gastrointestinal Motility Diagnosis Registry
|
||
Completed |
NCT00795093 -
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
|
N/A | |
Completed |
NCT00394472 -
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
|
Phase 2 | |
Completed |
NCT00574925 -
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
|
Phase 4 | |
Terminated |
NCT02749071 -
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
|
N/A | |
Recruiting |
NCT01129713 -
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
|
Phase 1/Phase 2 | |
Completed |
NCT00734747 -
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
Completed |
NCT00312806 -
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
|
Phase 3 | |
Not yet recruiting |
NCT05579587 -
Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
|
||
Recruiting |
NCT02366169 -
Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
|
N/A | |
Completed |
NCT01374074 -
Racial Disparity in Barrett's Esophagus
|
N/A | |
Terminated |
NCT00857597 -
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
|
Phase 3 |