Back to resultsA Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
Primary Purpose
Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
AH23844 (lavoltidine)
NEXIUM (esomeprazole)
ZANTAC (ranitidine)
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring tolerance, pharmacodynamics, ranitidine, esomeprazole, pharmacokinetics, gastroesophageal reflux disease (GERD), AH23844
Eligibility Criteria
Inclusion criteria:
- Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
- Subject does not present with abnormal clinical lab findings
- Subject is able to tolerate a nasogastric pH electrode.
Exclusion criteria:
- Subject is Helicobacter-positive on a C13 urea breath test
- Subject has a baseline median 24-hour gastric pH>3
- For Part B of the study, subjects are CYP 2C19 poor metabolizers.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
pH over 24hours
Secondary Outcome Measures
%24 hours pH>4 Median gastric pH Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00405119
Brief Title
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 (300mg/day) for the amount of pharmacodynamic tolerance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
Keywords
tolerance, pharmacodynamics, ranitidine, esomeprazole, pharmacokinetics, gastroesophageal reflux disease (GERD), AH23844
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AH23844 (lavoltidine)
Intervention Type
Drug
Intervention Name(s)
NEXIUM (esomeprazole)
Intervention Type
Drug
Intervention Name(s)
ZANTAC (ranitidine)
Other Intervention Name(s)
AH23844 (lavoltidine), NEXIUM (esomeprazole)
Primary Outcome Measure Information:
Title
pH over 24hours
Time Frame
over 24hours
Secondary Outcome Measure Information:
Title
%24 hours pH>4 Median gastric pH Adverse events
Time Frame
over 24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
Subject does not present with abnormal clinical lab findings
Subject is able to tolerate a nasogastric pH electrode.
Exclusion criteria:
Subject is Helicobacter-positive on a C13 urea breath test
Subject has a baseline median 24-hour gastric pH>3
For Part B of the study, subjects are CYP 2C19 poor metabolizers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
GSK Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
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