Gastroesophageal Reflux Disease Clinical Trial
Official title:
An Open-Label Study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg
NCT number | NCT00551473 |
Other study ID # | LAV110285 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | October 29, 2007 |
Last updated | May 31, 2012 |
Start date | May 2007 |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Randwick, Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | seven days | ||
Secondary | 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. | seven days |
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