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...
Date First Received: November 27, 2006
Last Updated: June 21, 2007
Verified by: GlaxoSmithKline, June 2007
Clinical Trial Phase: Phase 1 | Start Date: April 2006
Overall Status: Completed
Estimated Enrollment: 92
Brief Summary
Official Title: “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”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Intervention(s) in this Clinical Trial
- Drug: AH23844 (lavoltidine)
- Drug: NEXIUM (esomeprazole)
- Drug: ZANTAC (ranitidine)
Outcome Measures for this Clinical Trial
Primary Measures
- pH over 24hours
- Time Frame: over 24hours
- Time Frame: over 24hours
Secondary Measures
- %24 hours pH>4
Median gastric pH
Adverse events
- Time Frame: over 24 hours
- Time Frame: over 24 hours
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, BSc(Hons) MB BS PhD FRACP Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405119
Study ID Number: LAV104616
ClinicalTrials.gov Identifier: NCT00405119
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
