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

NCT ID: NCT00405119

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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

Conditions

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Gastroesophageal Reflux Disease Reflux, Gastroesophageal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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AH23844 (lavoltidine)

Intervention Type DRUG

NEXIUM (esomeprazole)

Intervention Type DRUG

ZANTAC (ranitidine)

Intervention Type DRUG

Other Intervention Names

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AH23844 (lavoltidine) NEXIUM (esomeprazole)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Randwick, New South Wales, Australia

Site Status

GSK Investigational Site

Herston, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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LAV104616

Identifier Type: -

Identifier Source: org_study_id

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