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Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00551473
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : June 4, 2012
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 lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Reflux, Gastroesophageal Drug: Lavoltidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-Label Study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD




Primary Outcome Measures :
  1. To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4. [ Time Frame: seven days ]

Secondary Outcome Measures :
  1. To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers. [ Time Frame: seven days ]


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:

  • Healthy male, from 18-55 years
  • Have BMI from 19-30 kg/m2
  • do not present with abnormal clinical lab findings
  • are able to tolerate a nasogastric pH electrode.

Exclusion Criteria:

  • Helicobacter-positive on a C13 urea breath test
  • have a baseline median 24-hour gastric pH>3

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): NCT00551473


Locations
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Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
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: NCT00551473    
Other Study ID Numbers: LAV110285
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: February 2011
Keywords provided by GlaxoSmithKline:
pharmacodynamics,
tolerance
H2 antagonist,
AH23844,
lavoltidine,
gastroesophageal reflux disease (GERD), pharmacokinetics,
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases