Gastroesophageal Reflux DiseasePhase 4NCT03037606
Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets
A Phase 4 study testing Rabelis DDR 50 mg Capsules and Pariet 20 mg Enteric Coated Tablets in people with Gastroesophageal Reflux Disease, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial summary
It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Rabelis DDR 50 mg Capsules and Pariet 20 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
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2017to 11 Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) at least 1 or more episodes a week.
- Age ≥ 18 years and <65 years
- Helicobacter pylori (an infection) negative
- Have a body mass index (BMI) between 18 and 33 kg/m²
- pH>4 gastric exposure <25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
- Pathologic intraesophageal acidity exposure (DeMeester score >14.75 and/or >4% of pH<4 (at least 21 hours measured)
Who cannot join
- Patiets with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
- Patients whose Hiatus hernia is > 3 cm.
- Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.
- Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (>450 ms for male, >470 ms for female patients).
- Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
- Patients with major psychiatric disease.
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- Alcoholism and drug use.
- Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.
- Malabsorbtion.
- Immunosuppressive patients.
- Patients taken cortisone.
- Patients taken other drugs that prolong QT interval.
- Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents, prostaglandin analogues, sukralfat.
- Pregnancy or breast-feeding.
- Patients taken drugs that may affect gastrointestinal system motility or acid release.
- History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).
- Patients taken NSAII drugs (paracetemol may be used up to 2 gr/day).
- Patients taken antidepressants.
- Hypersensitivty to study drugs.
- Known allergy to peanut and soy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Facult of Medicine Gastroenterology Department
Izmir, 35100
About this study
Official title: Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets on Intragastric and Intraesophageal Acidity
It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Rabelis DDR 50 mg Capsules, Pariet 20 mg Enteric Coated Tablets
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabelis DDR 50 mg CapsulesDrug
Rabelis DDR 50 mg Capsules once daily for seven days.
Pariet 20 mg Enteric Coated TabletsDrug
Pariet 20 mg Enteric Coated Tablets once daily for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Rabelis DDR 50 mg Capsules and 1 placebo tablet | Experimental | Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products. Receives: Drug: Rabelis DDR 50 mg Capsules |
| Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule | Active comparator | Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products. Receives: Drug: Pariet 20 mg Enteric Coated Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage time of 24-hour intragastric pH >4 compared to baseline
Measured: 7 days
AUC of 24-hour intragastric pH >4 compared to baseline
Measured: 7 days
Secondary outcomes (14)
Significant increase in total measurements of median pH
Measured: 7 days
Significant increase in nocturnal measurements of median pH
Measured: 7 days
Decrease in reflux symptom index calculated by weekly regurgitation numbers
Measured: 7 days
Decrease in reflux symptom index calculated by weekly pyrosis numbers
Measured: 7 days
Percentage time of 24-hour intragastric pH >2 compared to baseline
Measured: 7 days
Percentage time of 24-hour intragastric pH >6 compared to baseline
Measured: 7 days
AUC of 24-hour intragastric pH >2 compared to baseline
Measured: 7 days
AUC of 24-hour intragastric pH >6 compared to baseline
Measured: 7 days
Percentage time of 24-hour total intragastric pH >4 compared to baseline
Measured: 7 days
AUC of 24-hour total intragastric pH >4 compared to baseline
Measured: 7 days
Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline
rate of night reflux
Measured: 7 days
AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline
rate of night reflux
Measured: 7 days
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)
Measured: 7 days
Change in QT interval obtained by ECG compared to baseline
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Aug 2017
- Primary completion1 Dec 2018
- Study completion11 Dec 2018
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT03037606
- Sponsor's protocol ID
- NEU-03.16
- Status last verified
- Dec 2018
- First submitted
- 27 Jan 2017
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets on Intragastric and Intraesophageal Acidity
- ClinicalTrials.gov ID
- NCT03037606
- Acronym / sponsor ID
- NEU-03.16
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 31 Jan 2017 (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 compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rabelis DDR 50 mg Capsules and 1 placebo tablet | Experimental | Drug: Rabelis DDR 50 mg CapsulesPlacebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products. |
| Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule | Active comparator | Drug: Pariet 20 mg Enteric Coated TabletsPlacebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) at least 1 or more episodes a week.
- Age ≥ 18 years and <65 years
- Helicobacter pylori (an infection) negative
- Have a body mass index (BMI) between 18 and 33 kg/m²
- pH>4 gastric exposure <25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
Key exclusion criteria (20 listed)
- Patiets with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
- Patients whose Hiatus hernia is > 3 cm.
- Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.
- Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (>450 ms for male, >470 ms for female patients).
- Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
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 |
|---|---|---|
| Rabelis DDR 50 mg CapsulesRabelis DDR 50 mg Capsules once daily for seven days. | Drug | Rabelis DDR 50 mg Capsules and 1 placebo tablet |
| Pariet 20 mg Enteric Coated TabletsPariet 20 mg Enteric Coated Tablets once daily for seven days. | Drug | Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule |
Primary outcome
Percentage time of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
AUC of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
14 secondary outcomes
Significant increase in total measurements of median pH
Time frame: 7 days
Significant increase in nocturnal measurements of median pH
Time frame: 7 days
Decrease in reflux symptom index calculated by weekly regurgitation numbers
Time frame: 7 days
Decrease in reflux symptom index calculated by weekly pyrosis numbers
Time frame: 7 days
Percentage time of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
Percentage time of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
AUC of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
AUC of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
Percentage time of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
AUC of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline
Time frame: 7 days
AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline
Time frame: 7 days
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)
Time frame: 7 days
Change in QT interval obtained by ECG compared to baseline
Time frame: 21 days
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 12 Dec 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabelis DDR 50 mg Capsules and Pariet 20 mg Enteric Coated Tablets in people with Gastroesophageal Reflux Disease, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site 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 6 inclusion and 20 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 12 Dec 2018. 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 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?
Percentage time of 24-hour intragastric pH >4 compared to baseline (time frame: 7 days). 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 12 Dec 2018.