Gastroesophageal Reflux Disease (GERD)Phase 4NCT02689999
The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
A Phase 4 study testing Dexrabeprazole 10 mg Enteric-Coated Tablets in people with Gastroesophageal Reflux Disease (GERD), run by Neutec Ar-Ge San ve Tic A.Ş at 3 sites in Turkey (Türkiye).
Trial summary
It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and impedance kinetics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Dexrabeprazole 10 mg Enteric-Coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- Feb 2016to Aug 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of gastroesophageal reflux disease (GERD) in presence of pyrosis and/or regurgitation occurs once a week or more.
- Esophagitis stage A-B according to Los Angeles classification,
- Major symptom should be gastroesophageal reflux disease (GERD) in presence of overlapping symptoms,
- Age range should be 18-70 years,
- BMI should be 18-33 kg/m2,
- Presence of sufficient gastric acidity: Cases which intragastric ph > 4 value is under 25% according to dual multichannel intraluminal impedance-pH MII monitoring performed before study initiation,
- Pathologic intraesophageal acid exposure; DeMeester score > 14.75 and/or ph < 4 value > 4% (according to at 21 hour measurement at least),
- Helicobacter pylori should be negative according to biopsy in gastrointestinal system (GIS) endoscopy performed in last 12 months before study initiation; if biopsy not performed in endoscopy, stool antigen test or urease breath test should be performed and Helicobacter pylori should be negative.
Who cannot join
- Presence of food in stomach in gastrointestinal system (GIS) endoscopy performed in last 12 months before study initiation, all types of gastrointestinal system (GIS) pathology such as Barret stricture, stomach channel obstruction, malignity, gastrointestinal system (GIS) bleeding and cases with > 3 cm Hiatus hernia.
- Presence of severe chronic comorbid diseases; uncontrolled or insulin-dependent diabetes mellitus (IDDM), symptomatic gallbladder stone (cases who are asymptomatic and are not undergo cholecystitis and whose stone is 3 cm or polyp is smaller than 1 cm may be included), active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorders, pancreatitis, inflammatory bowel disease, chronic liver disease, severe liver disease, uncontrolled renal impairment, presence of cancer except non-melanoma skin cancer, heart failure, cerebrovascular disease, epilepsy,
- Major psychiatric disease,
- Alcoholism or cases take narcotics,
- Pathologic laboratory test; hemogram, sedimentation, C-reactive protein (CRP), thyroid function tests, liver enzymes,
- Malabsorption that may affect drug absorption,
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- Immunosuppressive and cortisone taking cases,
- Pregnancy or positive pregnancy test and lactating women,
- Cases taking all types of drugs which may affect gastrointestinal system motility or acid release,
- Cases undergo abdominal operation; hysterectomy, abdominal hernia operation, caesarean, appendectomies may be included but all types of cholecystectomy will be excluded.
- Cases taking a proton pomp inhibitor (PPI) and H2 blocker for last seven days and prokinetic drug for last three days,
- Condition that taking drugs need stomach acid for optimal absorption; such as ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents.
- Cases who must take prostaglandin analogs,
- Cases who must take non-steroidal anti-inflammatory drug (NSAID) during study,
- Cases taking antidepressants,
- Cases who refuse to sign informed consent,
- Hypersensitivity to study drug.
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Ankara University Gastroenterology Department
Ankara
Ege University Gastroenterology Department
Izmir, Bornova, 35100
On Dokuz Mayıs University Gastroenterology Department
Samsun
About this study
It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and impedance kinetics.
Read the detailed description
The participants will be on one week medication after two-weeks observation period. Intragastric and intraesophageal multichannel intraluminal impedance-pH (pH-MII) monitoring will be performed before and after medication. The pre- and post-treatment data will be compared. The safety tests will be performed during study in terms of possible side effects.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Dexrabeprazole 10 mg Enteric-Coated Tablets
- Keywords
- Gastroesophageal Reflux Disease (GERD), GERD, impedence
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexrabeprazole 10 mg Enteric-Coated TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexrabeprazole 10 mg Enteric-Coated Tablets | Experimental | Dexrabeprazole 10 mg Enteric-Coated Tablets / once daily Receives: Drug: Dexrabeprazole 10 mg Enteric-Coated Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
- The percent of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. Cases will be informed about adherence to the diet list, not to take anti-acids and need to press symptom button on device when complaints occur during 24-hour measurements. After 24 hours, results will be recorded and reported by transferring to computer environment. These results will be compared with measurement obtained in screening visit and then efficacy assessment will be done.
Measured: One week
- The area under curve (AUC) of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. Cases will be informed about adherence to the diet list, not to take anti-acids and need to press symptom button on device when complaints occur during 24-hour measurements. After 24 hours, results will be recorded and reported by transferring to computer environment. These results will be compared with measurement obtained in screening visit and then efficacy assessment will be done.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689999
- Sponsor's protocol ID
- NEU-01.15
- Status last verified
- Aug 2017
- First submitted
- 10 Feb 2016
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
- ClinicalTrials.gov ID
- NCT02689999
- Acronym / sponsor ID
- NEU-01.15
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Gastroesophageal Reflux Disease (GERD), GERD, impedence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Feb 2016 (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.
It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and impedance kinetics.
Detailed description
The participants will be on one week medication after two-weeks observation period. Intragastric and intraesophageal multichannel intraluminal impedance-pH (pH-MII) monitoring will be performed before and after medication. The pre- and post-treatment data will be compared. The safety tests will be performed during study in terms of possible side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexrabeprazole 10 mg Enteric-Coated Tablets | Experimental | Drug: Dexrabeprazole 10 mg Enteric-Coated TabletsDexrabeprazole 10 mg Enteric-Coated Tablets / once daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of gastroesophageal reflux disease (GERD) in presence of pyrosis and/or regurgitation occurs once a week or more.
- Esophagitis stage A-B according to Los Angeles classification,
- Major symptom should be gastroesophageal reflux disease (GERD) in presence of overlapping symptoms,
- Age range should be 18-70 years,
- BMI should be 18-33 kg/m2,
Key exclusion criteria (17 listed)
- Presence of food in stomach in gastrointestinal system (GIS) endoscopy performed in last 12 months before study initiation, all types of gastrointestinal system (GIS) pathology such as Barret stricture, stomach channel obstruction, malignity, gastrointestinal system (GIS) bleeding and cases with > 3 cm Hiatus hernia.
- Presence of severe chronic comorbid diseases; uncontrolled or insulin-dependent diabetes mellitus (IDDM), symptomatic gallbladder stone (cases who are asymptomatic and are not undergo cholecystitis and whose stone is 3 cm or polyp is smaller than 1 cm may be included), active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorders, pancreatitis, inflammatory bowel disease, chronic liver disease, severe liver disease, uncontrolled renal impairment, presence of cancer except non-melanoma skin cancer, heart failure, cerebrovascular disease, epilepsy,
- Major psychiatric disease,
- Alcoholism or cases take narcotics,
- Pathologic laboratory test; hemogram, sedimentation, C-reactive protein (CRP), thyroid function tests, liver enzymes,
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 |
|---|---|---|
| Dexrabeprazole 10 mg Enteric-Coated Tablets | Drug | Dexrabeprazole 10 mg Enteric-Coated Tablets |
Primary outcome
- The percent of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Time frame: One week
Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. Cases will be informed about adherence to the diet list, not to take anti-acids and need to press symptom button on device when complaints occur during 24-hour measurements. After 24 hours, results will be recorded and reported by transferring to computer environment. These results will be compared with measurement obtained in screening visit and then efficacy assessment will be done.
- The area under curve (AUC) of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Time frame: One week
Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. Cases will be informed about adherence to the diet list, not to take anti-acids and need to press symptom button on device when complaints occur during 24-hour measurements. After 24 hours, results will be recorded and reported by transferring to computer environment. These results will be compared with measurement obtained in screening visit and then efficacy assessment will be done.
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 24 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexrabeprazole 10 mg Enteric-Coated Tablets in people with Gastroesophageal Reflux Disease (GERD), run by Neutec Ar-Ge San ve Tic A.Ş at 3 sites in Turkey (Türkiye).
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 8 inclusion and 17 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
- The percent of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment. (time frame: One week). The study lists 2 primary outcomes in all. 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 24 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.