Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405119
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-11-27
Brief Title:
A Study To Investigate The Effectiveness Of AH234844 Lavoltidine Compared With NEXIUM And Ranitidine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-blind Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine Esomeprazole and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Current treatment for gastroesophageal reflux disease GERD confirms an unmet need in patients based on slow onset of action and an inability to provide 24-hour gastric-acid suppression Clinical data on AH234844 demonstrates a rapid onset of action high potency and prolonged duration of effect The present study endeavors in part to compare lavoltidine to two GERD drugs NEXIUM and ranitidine
Detailed Description:
A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM esomeprazole 40mg for the inhibition of gastric-acid secretion and with ranitidine 300mgday for the amount of pharmacodynamic tolerance
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