A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405119
• Other study ID #: LAV104616
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2006
• Last updated: January 18, 2017
• Start date: May 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Reflux, Gastroesophageal

Intervention

Drug:
• AH23844 (lavoltidine)

• NEXIUM (esomeprazole)

• ZANTAC (ranitidine)

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH over 24hours		over 24hours
Secondary	%24 hours pH>4 Median gastric pH Adverse events		over 24 hours