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The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexrabeprazole 10 mg Enteric-Coated Tablets
Sponsored by
Neutec Ar-Ge San ve Tic A.Ş
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal Reflux Disease (GERD), GERD, impedence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Sites / Locations

  • Ege University Gastroenterology Department
  • Ankara University Gastroenterology Department
  • On Dokuz Mayıs University Gastroenterology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexrabeprazole 10 mg Enteric-Coated Tablets

Arm Description

Dexrabeprazole 10 mg Enteric-Coated Tablets / once daily

Outcomes

Primary Outcome Measures

- 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.
- 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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2016
Last Updated
August 23, 2017
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
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1. Study Identification

Unique Protocol Identification Number
NCT02689999
Brief Title
The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
Official Title
The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Gastroesophageal Reflux Disease (GERD), GERD, impedence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexrabeprazole 10 mg Enteric-Coated Tablets
Arm Type
Experimental
Arm Description
Dexrabeprazole 10 mg Enteric-Coated Tablets / once daily
Intervention Type
Drug
Intervention Name(s)
Dexrabeprazole 10 mg Enteric-Coated Tablets
Primary Outcome Measure Information:
Title
- The percent of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Description
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.
Time Frame
One week
Title
- The area under curve (AUC) of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Description
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.
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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, 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.
Facility Information:
Facility Name
Ege University Gastroenterology Department
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Ankara University Gastroenterology Department
City
Ankara
Country
Turkey
Facility Name
On Dokuz Mayıs University Gastroenterology Department
City
Samsun
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity

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