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OpenTrials
Completed

NCT Number: NCT00405119

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Reflux, Gastroesophageal

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Randwick, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AH23844 (lavoltidine)

Drug

Nexium (esomeprazole)

Drug

ZANTAC (ranitidine)

Drug

Other names: AH23844 (lavoltidine), NEXIUM (esomeprazole)

Primary outcomes

  1. pH over 24hours

    Time frame: over 24hours

Secondary outcomes

  1. %24 hours pH>4 Median gastric pH Adverse events

    Time frame: over 24 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 29, 2006
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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