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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00405119
Other study ID # LAV104616
Secondary ID
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
Health authority
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.

Study Design


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
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