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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00551473
• Collaborator: (none)
• Enrollment: 18
• Location: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 1, 2007

Outcome Measures

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. [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. [seven days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Randwick, Sydney	New South Wales	Australia	2031

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00551473
• Other Study ID Numbers: LAV110285
• First Posted: Oct 31, 2007
• Last Update Posted: Jun 4, 2012
• Last Verified: Feb 1, 2011

• Keywords provided by GlaxoSmithKline: pharmacodynamics,; tolerance; H2 antagonist,; AH23844,; lavoltidine,; gastroesophageal reflux disease (GERD), pharmacokinetics,
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Jun 4, 2012