Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336219
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2006-06-12
Brief Title:
Symptom Assessment in Adult Patients With Erosive GERD Gastroesophageal Reflux Disease or enGERD Endoscopic-negative GERD After Treatment With Pantoprazole BY1023M3-343
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
COMPETITION Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease GERD Symptom Changes
Status:
COMPLETED
Status Verified Date:
2008-10
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:
The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD enGERD An endoscopy will be performed at study start and study end During the study the patients will complete a patient-orientated self-assessed reflux questionnaire ReQuest questionnaire The study duration consists of a baseline period 8 days and treatment period 28 days Pantoprazole tablet will be administered once daily at one dose level 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