RefluxPhase 1NCT00216788
The Effect of Nexium on Transmucosal Esophageal Leak
A Phase 1 study testing Esomeprazole (Nexium) 40 mg/day in people with Reflux and Esophagitis, run by Main Line Health at 1 site in United States.
Trial summary
In a related study, the investigators have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the blood, and be filtered into urine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reflux, Esophagitis, Barrett's Esophagus
- What is being tested?
- Esomeprazole (Nexium) 40 mg/day
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2006
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to a general practitioner / internist with symptoms of GERD defined as:
- Heartburn - uncomfortable, rising, burning sensation behind the breastbone
- Regurgitation of gastric acid or sour contents into the mouth
- Chest pain atypical for cardiac ischemia and more suggestive of GERD
- Symptoms for more than three weeks with no concurrent use of PPI's or H-2 blockers during that time period
- A score greater than or equal to 5 on the AstraZeneca RDQ
Who cannot join
- Any patients presenting with alarm symptoms (GI bleeding, dysphagia, weight loss, abdominal mass, lymphadenopathy, or recurrent vomiting)
- Diabetes (type I or II)
- Renal insufficiency defined as creatinine >1.6
- Under 18 years of age
- Prior surgery on esophagus, stomach or duodenum
- History of gastric/duodenal ulcers
Show all 11Show fewer
- History of H. pylori
- Known history of Barrett's esophagus (recruited to parallel study)
- On Coumadin or Heparin therapy
- Chronic upper abdominal pain more consistent with dyspepsia or other diagnoses
- Noncompliant patients
Trial locations and contacts
1 site in 1 country.
Daniel Lazowick, D.O. contact
Gambril Murray, M.D. contact
United States1 site
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Daniel Lazowick, D.O., 610-645-6555
Daniel Lazowick, D.O.
About this study
Official title: The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak
In a related study, the investigators have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. The investigators predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
Read the detailed description
In a related study, we have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave the lumen of their upper gastrointestinal tract, enter the blood, and be filtered into urine. Normally the disaccharide sucrose cannot leave the lumen of the gastrointestinal tract without being first hydrolyzed to glucose and fructose. Appearance of the disaccharide in the bloodstream suggests a paracellular leak of some type in the upper gastrointestinal tract. Once in the blood, sucrose is likewise not taken up or metabolized by the kidney but simply filtered into the urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. We predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
In this study, patients over 18 years of age presenting with GERD symptoms to a primary care physician, will be recruited after providing informed consent. Patients will perform a sucrose leak test the evening after their recruitment by drinking a solution of 100 gms of sucrose in 200 cc of water at bedtime, then collecting an overnight urine sample (8 hrs). Within 5 days the patient will undergo an upper endoscopy exam. The patient will then begin Nexium therapy (40 mg/day of Esomeprazole) for 8 weeks, taking the dose each morning before breakfast. After 8 weeks the patient will undergo a second sucrose leak test as described above. Urine sucrose will be determined by HPLC.
- Conditions
- Reflux, Esophagitis, Barrett's Esophagus
- Being tested
- Esomeprazole (Nexium) 40 mg/day
- Keywords
- Sucrose, Barrett's esophagus, Esophagitis, GERD, Reflux, Esophagus, Esomeprazole
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole (Nexium) 40 mg/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine sucrose level falls below 90 mg after 8 weeks of therapy
Secondary outcomes (1)
Reduction of patient symptoms consistent with GERD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2006
- Study completionJan 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RefluxStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Sharpe-Strumia Research Foundation, Cancer Research Foundation of America
- Investigators
- James M Mullin, Ph.D., Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216788
- Sponsor's protocol ID
- IRUSESOM0388
- Status last verified
- Nov 2005
- First submitted
- 19 Sep 2005
- Last updated
- 16 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak
- ClinicalTrials.gov ID
- NCT00216788
- Acronym / sponsor ID
- IRUSESOM0388
- Conditions
- Reflux, Esophagitis, Barrett's Esophagus
- Keywords
- Sucrose, Barrett's esophagus, Esophagitis, GERD, Reflux, Esophagus, Esomeprazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- AstraZeneca, Sharpe-Strumia Research Foundation, Cancer Research Foundation of America
- Study start
- Jan 2006
- Study completion
- Jan 2006 (estimated)
- First posted
- 22 Sep 2005 (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.
In a related study, the investigators have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. The investigators predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
Detailed description
In a related study, we have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave the lumen of their upper gastrointestinal tract, enter the blood, and be filtered into urine. Normally the disaccharide sucrose cannot leave the lumen of the gastrointestinal tract without being first hydrolyzed to glucose and fructose. Appearance of the disaccharide in the bloodstream suggests a paracellular leak of some type in the upper gastrointestinal tract. Once in the blood, sucrose is likewise not taken up or metabolized by the kidney but simply filtered into the urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. We predict that Nexium will reduce leak in esophagitis but not Barrett's patients.
In this study, patients over 18 years of age presenting with GERD symptoms to a primary care physician, will be recruited after providing informed consent. Patients will perform a sucrose leak test the evening after their recruitment by drinking a solution of 100 gms of sucrose in 200 cc of water at bedtime, then collecting an overnight urine sample (8 hrs). Within 5 days the patient will undergo an upper endoscopy exam. The patient will then begin Nexium therapy (40 mg/day of Esomeprazole) for 8 weeks, taking the dose each morning before breakfast. After 8 weeks the patient will undergo a second sucrose leak test as described above. Urine sucrose will be determined by HPLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting to a general practitioner / internist with symptoms of GERD defined as:
- Heartburn - uncomfortable, rising, burning sensation behind the breastbone
- Regurgitation of gastric acid or sour contents into the mouth
- Chest pain atypical for cardiac ischemia and more suggestive of GERD
- Symptoms for more than three weeks with no concurrent use of PPI's or H-2 blockers during that time period
Key exclusion criteria (11 listed)
- Any patients presenting with alarm symptoms (GI bleeding, dysphagia, weight loss, abdominal mass, lymphadenopathy, or recurrent vomiting)
- Diabetes (type I or II)
- Renal insufficiency defined as creatinine >1.6
- Under 18 years of age
- Prior surgery on esophagus, stomach or duodenum
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 |
|---|---|---|
| Esomeprazole (Nexium) 40 mg/day | Drug | – |
Primary outcome
Urine sucrose level falls below 90 mg after 8 weeks of therapy
1 secondary outcome
Reduction of patient symptoms consistent with GERD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
- Related InfoLink provided by the sponsor.
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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.
Daniel Lazowick, D.O. contact
Gambril Murray, M.D. contact
James M Mullin, Ph.D. principal investigator
Main Line Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esomeprazole (Nexium) 40 mg/day in people with Reflux and Esophagitis, run by Main Line Health at 1 site in United States.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lazowick, D.O. (610-645-6555), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine sucrose level falls below 90 mg after 8 weeks of therapy. 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 16 Mar 2010.