Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246909
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2005-10-31
Brief Title:
Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux Gastroesophageal Reflux Disease BY1023M3-340
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Determination of the Minimal Clinically Important Difference MCID of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease GERD Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg od or Placebo od Over One Week
Status:
COMPLETED
Status Verified Date:
2011-06
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 reflux symptoms daily Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients
Of particular interest in GERD is the assessment of symptom severity and quality of life and the response of these parameters to treatment Therefore a questionnaire to assess GERD symptoms was developed ReQuest TradeMark An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect
The aim of this study is to determine the minimal clinically important difference MCID in patients diagnosed with GERD During the study the patients will complete a patient-orientated self-assessed reflux questionnaire ReQuest TradeMark Endoscopy will be performed at the start of the study The study duration consists of a baseline period 1 to 3 weeks and a treatment period 8 weeks During the first treatment week the patients will receive either pantoprazole tablet or placebo once daily in the morning for the following 7 treatment weeks all patients will receive pantoprazole The study will provide further data on safety and tolerability of pantoprazole
Of particular interest in GERD is the assessment of symptom severity and quality of life and the response of these parameters to treatment Therefore a questionnaire to assess GERD symptoms was developed ReQuest TradeMark An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect
The aim of this study is to determine the minimal clinically important difference MCID in patients diagnosed with GERD During the study the patients will complete a patient-orientated self-assessed reflux questionnaire ReQuest TradeMark Endoscopy will be performed at the start of the study The study duration consists of a baseline period 1 to 3 weeks and a treatment period 8 weeks During the first treatment week the patients will receive either pantoprazole tablet or placebo once daily in the morning for the following 7 treatment weeks all patients will receive pantoprazole 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