Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163306
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2005-09-12
Brief Title:
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux Gastroesophageal Reflux Disease BY1023M3-339
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Complete Remission Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease NERD or Erosive Gastroesophageal Reflux Disease GERD Treated With Pantoprazole 40 Milligram od Over 4 or 8 or 12 Weeks
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastroesophageal reflux disease GERD is a medical condition affecting the stomach and esophagus GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back refluxes into the esophagus GERD is one of the most common medical disorders with estimates of up to 50 of adults reporting symptoms related to gastric reflux Proton pump inhibitors PPI such as pantoprazole can relieve symptoms of GERD in a large proportion of patients
When refluxed stomach acidic content touches the lining of the esophagus it causes a burning sensation in the chest or throat This sensation is often referred to as heartburn Some patients have symptoms of GERD without visible destruction of the tissue surface no visible changes by endoscopic examination
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period Pantoprazole will be administered once daily in the morning Endoscopy will be performed at the start of the study and then as required after 4 8 or 12 weeks The study will provide further data on safety and tolerability of pantoprazole
When refluxed stomach acidic content touches the lining of the esophagus it causes a burning sensation in the chest or throat This sensation is often referred to as heartburn Some patients have symptoms of GERD without visible destruction of the tissue surface no visible changes by endoscopic examination
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period Pantoprazole will be administered once daily in the morning Endoscopy will be performed at the start of the study and then as required after 4 8 or 12 weeks The study will provide further data on safety and tolerability of pantoprazole
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None