The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
NCT ID: NCT02689999
Last Updated: 2017-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2016-02-29
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dexrabeprazole 10 mg Enteric-Coated Tablets
Dexrabeprazole 10 mg Enteric-Coated Tablets / once daily
Dexrabeprazole 10 mg Enteric-Coated Tablets
Interventions
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Dexrabeprazole 10 mg Enteric-Coated Tablets
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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,
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Neutec Ar-Ge San ve Tic A.Ş
INDUSTRY
Responsible Party
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Locations
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Ege University Gastroenterology Department
Izmir, Bornova, Turkey (Türkiye)
Ankara University Gastroenterology Department
Ankara, , Turkey (Türkiye)
On Dokuz Mayıs University Gastroenterology Department
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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NEU-01.15
Identifier Type: -
Identifier Source: org_study_id
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