Ignite Creation Date:
2024-05-05 @ 11:22 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01315444
Status:
WITHDRAWN
Last Update Posted:
2017-10-05
First Post:
2011-03-13
Brief Title:
Gastric Acid Rebound Secretion Measured by Alkaline Tide
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Gradual Cessation of Proton Pump Inhibitor PPI Treatment May Prevent Rebound Acid Secretion in Dyspeptic and Reflux Patients Measured by the Alkaline Tide Method
Status:
WITHDRAWN
Status Verified Date:
2017-10
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:
Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia attacks 20 of the Western population These millions of patients are treated continuously with PPI for different periods many for many years Recently rebound acid hypersecretion was recognized as a major clinical event after cessation of PPI therapy Sustained hypergastrinemia due to daily PPI therapy causes increased acid-secretory capacity that appears when the drug is stopped The transient increase in blood and urinary pH following gastric secretion has been termed the alkaline tide phenomenon Carbonic acid formed in the presence of the enzyme carbonic anhydrase neutralizes intracellular hydroxyl ions produced as a result of luminal acid secretion The bicarbonate generated is removed from the cell via the baso-lateral chloride bicarbonate exchanger The investigators have shown in several studies that this phenomenon parallels acid secretion Thus stimulation of acid secretion with test meal increased base excess maximally after 45 minutes and these changes parallel peak acid output measured in gastric aspirate The investigators hypothesize that gradual step down cessation of PPI will prevent this clinical relevant event By measuring alkaline tide after PPI cessation the investigators may prove this hypothesis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RMC 101 | OTHER | RMC 101 | None |