Gastroesophageal Reflux DiseaseNCT00539786
The Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD
A study testing Proton pump inhibitor (rabeprazole) in people with Gastroesophageal Reflux Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Proton pump inhibitor (rabeprazole)
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Apr 2011
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with extraesophageal manifestation symptoms of GERD
Who cannot join
- laryngeal, pharyngeal, liver, lung, renal, or hematological disorders
- a history of gastrointestinal surgery, and a history of connective tissue disorders.
- patients with duodenal or gastric ulcers as well as other significant lesions, such as gastric cancer, esophageal cancer, or subepithelial tumors more than 1 cm observed on the upper endoscopy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Gangnam-gu, 135-710
Poong Lyul Rhee, M.D., Ph.D, +82-2-3410-3409, plrhee@skku.edu
Poong-Lyul Rhee, M.D., Ph.D.
About this study
Official title: Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms
PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. In this study, we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal symptoms.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Proton pump inhibitor (rabeprazole)
- Keywords
- Patients with extraesophageal manifestation of gastroesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton pump inhibitor (rabeprazole)Drug
Patients receives rabeprazole 20mg AM and 20mg PM for 14 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom responders after PPI trials
Measured: 2 weeks after PPI trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startMar 2006
- Primary completionApr 2011
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 Samsung Medical CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poong-Lyul Rhee, Samsung Medical Center
- Investigators
- Poong-Lyul Rhee, MD. Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539786
- Sponsor's protocol ID
- 2006-03-071
- Status last verified
- May 2014
- First submitted
- 3 Oct 2007
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Proton Pump Inhibitor Test for Identifying Gastroesophageal Reflux Disease in Patients With Extraesophageal Symptoms
- ClinicalTrials.gov ID
- NCT00539786
- Acronym / sponsor ID
- 2006-03-071
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Patients with extraesophageal manifestation of gastroesophageal reflux disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Apr 2011 (actual)
- First posted
- 5 Oct 2007 (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.
PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. In this study, we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal symptoms.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with extraesophageal manifestation symptoms of GERD
Key exclusion criteria (3 listed)
- laryngeal, pharyngeal, liver, lung, renal, or hematological disorders
- a history of gastrointestinal surgery, and a history of connective tissue disorders.
- patients with duodenal or gastric ulcers as well as other significant lesions, such as gastric cancer, esophageal cancer, or subepithelial tumors more than 1 cm observed on the upper endoscopy
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 |
|---|---|---|
| Proton pump inhibitor (rabeprazole)Patients receives rabeprazole 20mg AM and 20mg PM for 14 days | Drug | – |
Primary outcome
Symptom responders after PPI trials
Time frame: 2 weeks after PPI trials
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Poong-Lyul Rhee, MD. Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton pump inhibitor (rabeprazole) in people with Gastroesophageal Reflux Disease, run by Samsung Medical Center at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 16 May 2014. 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 South Korea. 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.
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 Tae ggon Kim (+82-2-3410-2975, tggo.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom responders after PPI trials (time frame: 2 weeks after PPI trials). 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 May 2014.