Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01373970
Status:
TERMINATED
Last Update Posted:
2013-12-06
First Post:
2011-05-17
Brief Title:
The Clinical Significance of Acid Rebound in Functional Dyspepsia
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
The Clinical Significance of Acid Rebound Symptoms of Reflux After PPI Treatment in Patients With Functional Dyspepsia
Status:
TERMINATED
Status Verified Date:
2013-12
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:
CLARIFY
Brief Summary:
Proton pump inhibitors PPI have been shown to cause acid reflux related symptoms at withdrawal in healthy volunteers a phenomenon known as Rebound Acid Hyper Secretion Whether this also applies for patients with dyspeptic symptoms but without true reflux disease functional dyspepsia treated with PPI is unknown If this is the case it could lead to an unfortunate long term use of PPI since the acid rebound renders withdrawal too difficult
This is a single centre randomized double-blinded placebo-controlled cross over study Study period is 12 weeks per study subject Study subjects are referred to the study from General Practitioner GP and the gastroenterology department or endoscopy clinic of the investigational centre
The study population consists of patients who seek their GP because of dyspepsia without alert signs and whom the GP may consider starting on PPI Out patients referred to the gastroenterology department or endoscopy clinic of the investigational centre because of dyspepsia without specific exclusion criteria are also invited to participate
Baseline interview upper endoscopy and pH monitoring are performed one week before inclusion to exclude patients with GERD Helicobacter Pylori Hp status is assessed by Helicobacter Urease Test HUT Hp positive subjects without ulcus are not excluded
Patients with a positive pH monitoring will not be included in the analysis regarding the primary endpoint Development of GERD but will be included in the analysis regarding one of the secondary endpoints Effect of PPI on Functional Dyspepsia
Study subjects are randomized to either pantoprazol followed by cross over to placebo or to placebo Escape medication in the form of Gaviscon can be used on demand
Internet based questionnaires are answered weekly Questionnaires consist of the Gastrointestinal Symptom rating Scale GSRS in combination with items assessing postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease GERD
Compliance to protocol is assessed at hospital visits every fourth week At the end of study endoscopy and pH monitoring are repeated
This is a single centre randomized double-blinded placebo-controlled cross over study Study period is 12 weeks per study subject Study subjects are referred to the study from General Practitioner GP and the gastroenterology department or endoscopy clinic of the investigational centre
The study population consists of patients who seek their GP because of dyspepsia without alert signs and whom the GP may consider starting on PPI Out patients referred to the gastroenterology department or endoscopy clinic of the investigational centre because of dyspepsia without specific exclusion criteria are also invited to participate
Baseline interview upper endoscopy and pH monitoring are performed one week before inclusion to exclude patients with GERD Helicobacter Pylori Hp status is assessed by Helicobacter Urease Test HUT Hp positive subjects without ulcus are not excluded
Patients with a positive pH monitoring will not be included in the analysis regarding the primary endpoint Development of GERD but will be included in the analysis regarding one of the secondary endpoints Effect of PPI on Functional Dyspepsia
Study subjects are randomized to either pantoprazol followed by cross over to placebo or to placebo Escape medication in the form of Gaviscon can be used on demand
Internet based questionnaires are answered weekly Questionnaires consist of the Gastrointestinal Symptom rating Scale GSRS in combination with items assessing postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease GERD
Compliance to protocol is assessed at hospital visits every fourth week At the end of study endoscopy and pH monitoring are repeated
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