Gastroesophageal Reflux DiseasePhase 2NCT00405119
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
A Phase 2 study testing AH23844 (lavoltidine), NEXIUM (esomeprazole) and ZANTAC (ranitidine) in people with Gastroesophageal Reflux Disease and Reflux, Gastroesophageal, run by GlaxoSmithKline at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Reflux, Gastroesophageal
- What is being tested?
- AH23844 (lavoltidine), NEXIUM (esomeprazole) and ZANTAC (ranitidine)
- How many people
- 92 participants
- Where
- 2 sitesAustralia
- Study dates
- May 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
GSK Investigational Site
Herston, Queensland, 4006
GSK Investigational Site
Randwick, New South Wales, 2031
About this study
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
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.
Read the 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
- Being tested
- AH23844 (lavoltidine), NEXIUM (esomeprazole), ZANTAC (ranitidine)
- Keywords
- tolerance, pharmacodynamics, ranitidine, esomeprazole, pharmacokinetics, gastroesophageal reflux disease (GERD), AH23844
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH23844 (lavoltidine)Drug
NEXIUM (esomeprazole)Drug
ZANTAC (ranitidine)Drug
Also called AH23844 (lavoltidine), NEXIUM (esomeprazole)
What is being measured
The primary outcome is the main question the study is designed to answer.
pH over 24hours
Measured: over 24hours
Secondary outcomes (1)
%24 hours pH>4 Median gastric pH Adverse events
Measured: over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405119
- Sponsor's protocol ID
- LAV104616
- Status last verified
- Jan 2017
- First submitted
- 27 Nov 2006
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00405119
- Acronym / sponsor ID
- LAV104616
- Keywords
- tolerance, pharmacodynamics, ranitidine, esomeprazole, pharmacokinetics, gastroesophageal reflux disease (GERD), AH23844
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 29 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AH23844 (lavoltidine) | Drug | – |
| NEXIUM (esomeprazole) | Drug | – |
| ZANTAC (ranitidine)Also: AH23844 (lavoltidine), NEXIUM (esomeprazole) | Drug | – |
Primary outcome
pH over 24hours
Time frame: over 24hours
1 secondary outcome
%24 hours pH>4 Median gastric pH Adverse events
Time frame: over 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AH23844 (lavoltidine), NEXIUM (esomeprazole) and ZANTAC (ranitidine) in people with Gastroesophageal Reflux Disease and Reflux, Gastroesophageal, run by GlaxoSmithKline at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH over 24hours (time frame: over 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.