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

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ClinicalTrials.gov Identifier: NCT00405119
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Reflux, Gastroesophageal Drug: AH23844 (lavoltidine) Drug: NEXIUM (esomeprazole) Drug: ZANTAC (ranitidine) Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
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 Start Date : May 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD


Intervention Details:
  • Drug: AH23844 (lavoltidine)
  • Drug: NEXIUM (esomeprazole)
  • Drug: ZANTAC (ranitidine)
    Other Names:
    • AH23844 (lavoltidine)
    • NEXIUM (esomeprazole)


Primary Outcome Measures :
  1. pH over 24hours [ Time Frame: over 24hours ]

Secondary Outcome Measures :
  1. %24 hours pH>4 Median gastric pH Adverse events [ Time Frame: over 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405119


Locations
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Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00405119     History of Changes
Other Study ID Numbers: LAV104616
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Keywords provided by GlaxoSmithKline:
tolerance
pharmacodynamics
ranitidine
esomeprazole
pharmacokinetics
gastroesophageal reflux disease (GERD)
AH23844
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Ranitidine
Ranitidine bismuth citrate
Loxtidine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs