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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00405119
• Collaborator: (none)
• Enrollment: 92
• Locations: 2
• Duration (Months): 10
• Patients Per Site: 46
• Patients Per Site Per Month: 4.6

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 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

Study Design

• Study Type: Interventional
• 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 1, 2006
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. pH over 24hours [over 24hours]

Secondary Outcome Measures

1. %24 hours pH>4 Median gastric pH Adverse events [over 24 hours]

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Randwick	New South Wales	Australia	2031
2	GSK Investigational Site	Herston	Queensland	Australia	4006

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: NCT00405119
• Other Study ID Numbers: LAV104616
• First Posted: Nov 29, 2006
• Last Update Posted: Jan 19, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by GlaxoSmithKline: tolerance; pharmacodynamics; ranitidine; esomeprazole; pharmacokinetics; gastroesophageal reflux disease (GERD); AH23844
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esomeprazole; Ranitidine; Ranitidine bismuth citrate; Loxtidine

Study Results

No Results Posted as of Jan 19, 2017