Esophageal RefluxPhase 2NCT00222170
Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)
A Phase 2 study testing Rabeprazole in people with Esophageal Reflux, run by University of Kansas at 1 site in United States.
Trial summary
The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Esophageal Reflux
- What is being tested?
- Rabeprazole
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to May 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (Grades A-D according to LA classification) in patients with chronic symptoms of GERD (heartburn with or without regurgitation) between the age of 19 and 79, 12M \& 12F, will be included.
Exclusion criteria: History of GI surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called "dry mouth syndrome").
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Esophagoprotection by Rabeprazole Mediated by Restoration of an Impairment in Esophageal Mucin Production: Its Potential Therapeutic Benefit in Patients With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.
Read the detailed description
Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.
- Conditions
- Esophageal Reflux
- Being tested
- Rabeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RabeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole
Secondary outcomes (1)
Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy
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 startMay 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
- Investigators
- Jerzy Sarosiek, PhD, Principal investigator, University of Kansas Medical CenterMojtaba S. Olyaee, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222170
- Sponsor's protocol ID
- RE Study
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2005
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagoprotection by Rabeprazole Mediated by Restoration of an Impairment in Esophageal Mucin Production: Its Potential Therapeutic Benefit in Patients With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00222170
- Acronym / sponsor ID
- RE Study
- Conditions
- Esophageal Reflux
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
- Study start
- May 2005
- Study completion
- May 2007 (actual)
- 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.
The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.
Detailed description
Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Rabeprazole | Drug | – |
Primary outcome
Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole
1 secondary outcome
Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy
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 8 May 2009.
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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.
Jerzy Sarosiek, PhD principal investigator
University of Kansas Medical Center
Mojtaba S. Olyaee, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rabeprazole in people with Esophageal Reflux, run by University of Kansas 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?
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 8 May 2009. 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 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?
Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole. 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 8 May 2009.