Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261339
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2005-12-02
Brief Title:
Determination of a Questionnaire After Treatment With Pantoprazole at Full Dose and Half Dose in Adult Patients With Symptoms of Acid Reflux Gastroesophageal Reflux Disease BY1023UK-506
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
PRISM Determination of the Performance Characteristics of ReQuest TradeMark in Practice in the Stepped Down Management of GORD
Status:
COMPLETED
Status Verified Date:
2006-12
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 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 to treatment Therefore a questionnaire was developed to assess GERD symptoms ReQuest TradeMark in Practice An important point to consider when using such a questionnaire is to follow the patients medical response to treatment and note whether a patient needs to change dosing such as changing from full dose to half dose or vice versa
The aim of the study is to determine the value of the questionnaire ReQuest TradeMark in Practice according to treating physicians clinical judgment when using pantoprazole at full and half dose The study duration consists of a pre-treatment periods 0-2 weeks and two treatment period 8 weeks each During the first treatment period pantoprazole will be administered once daily at full dose 40 mg During the second treatment period pantoprazole will be administered once daily at half dose 20 mg 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 to treatment Therefore a questionnaire was developed to assess GERD symptoms ReQuest TradeMark in Practice An important point to consider when using such a questionnaire is to follow the patients medical response to treatment and note whether a patient needs to change dosing such as changing from full dose to half dose or vice versa
The aim of the study is to determine the value of the questionnaire ReQuest TradeMark in Practice according to treating physicians clinical judgment when using pantoprazole at full and half dose The study duration consists of a pre-treatment periods 0-2 weeks and two treatment period 8 weeks each During the first treatment period pantoprazole will be administered once daily at full dose 40 mg During the second treatment period pantoprazole will be administered once daily at half dose 20 mg 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