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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabelis DDR 50 mg Capsules | Drug | Rabelis DDR 50 mg Capsules once daily for seven days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage time of 24-hour intragastric pH >4 compared to baseline | 7 days | |
| AUC of 24-hour intragastric pH >4 compared to baseline | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Significant increase in total measurements of median pH | 7 days | |
| Significant increase in nocturnal measurements of median pH | 7 days | |
| Decrease in reflux symptom index calculated by weekly regurgitation numbers |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Facult of Medicine Gastroenterology Department | Izmir | 35100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pariet 20 mg Enteric Coated Tablets | Drug | Pariet 20 mg Enteric Coated Tablets once daily for seven days. |
|
| 7 days |
| Decrease in reflux symptom index calculated by weekly pyrosis numbers | 7 days |
| Percentage time of 24-hour intragastric pH >2 compared to baseline | 7 days |
| Percentage time of 24-hour intragastric pH >6 compared to baseline | 7 days |
| AUC of 24-hour intragastric pH >2 compared to baseline | 7 days |
| AUC of 24-hour intragastric pH >6 compared to baseline | 7 days |
| Percentage time of 24-hour total intragastric pH >4 compared to baseline | 7 days |
| AUC of 24-hour total intragastric pH >4 compared to baseline | 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 | 7 days |
| AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline | rate of night reflux | 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) | 7 days |
| Change in QT interval obtained by ECG compared to baseline | 21 days |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |