NCT00405119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

November 27, 2006

Last Update Submit

January 18, 2017

Conditions

Gastroesophageal Reflux DiseaseReflux, Gastroesophageal

Keywords

tolerancepharmacodynamicsranitidineesomeprazolepharmacokineticsgastroesophageal reflux disease (GERD)AH23844

Outcome Measures

Primary Outcomes (1)

  • pH over 24hours

    over 24hours

Secondary Outcomes (1)

  • %24 hours pH>4 Median gastric pH Adverse events

    over 24 hours

Interventions

AH23844 (lavoltidine)DRUG
NEXIUM (esomeprazole)DRUG
ZANTAC (ranitidine)DRUG
Also known as: AH23844 (lavoltidine), NEXIUM (esomeprazole)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

GSK Investigational Site

Herston, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

loxtidineEsomeprazoleRanitidine

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFurans

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 29, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

AU(2)