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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00405119




Registration number
NCT00405119
Ethics application status
Date submitted
27/11/2006
Date registered
29/11/2006
Date last updated
19/01/2017

Titles & IDs
Public title
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
Scientific 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
Secondary ID [1] 0 0
LAV104616
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease 0 0
Reflux, Gastroesophageal 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AH23844 (lavoltidine)
Treatment: Drugs - NEXIUM (esomeprazole)
Treatment: Drugs - ZANTAC (ranitidine)

Treatment: Drugs: AH23844 (lavoltidine)


Treatment: Drugs: NEXIUM (esomeprazole)


Treatment: Drugs: ZANTAC (ranitidine)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
pH over 24hours
Timepoint [1] 0 0
over 24hours
Secondary outcome [1] 0 0
%24 hours pH>4 Median gastric pH Adverse events
Timepoint [1] 0 0
over 24 hours

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Herston
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00405119
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00405119