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The sponsor decided to continue with a different design and a different protocol.
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The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name: Lasotab) in GERD patients in terms of cardiac safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole/Domperidone | Experimental | Patient will be administered lansoprazole/domperidone 30/30 mg capsules (brand name: Duolans) half an hour before breakfast for eight weeks according to randomisation scheme. |
|
| Lansoprazole | Active Comparator | Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole/Domperidone | Combination Product | Experimental |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in QT and corrected QT (QTc) interval compared to baseline | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in upper gastrointestinal symptom severity index compared to baseline. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serhat Bor, Prof Dr | Ege University Medical Faculty Gastroenterology Dep. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başkent University Hospital Gastroenterology Dep. | Adana | Turkey (Türkiye) | ||||
| Çukurova University Medical Faculty Cardiology Dep. |
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| Lansoprazole | Drug | Active comparator |
|
|
| Adana |
| Turkey (Türkiye) |
| Ankara University Medical Faculty Gastroenterology Dep. | Ankara | Turkey (Türkiye) |
| Dışkapı Research and Training Hospital Gastroenterology Dep. | Ankara | Turkey (Türkiye) |
| Yüksek İhtisas Research and Training Hospital Gastroenterology Dep. | Ankara | Turkey (Türkiye) |
| Antalya Research and Training Hospital Gastroenterology Dep. | Antalya | Turkey (Türkiye) |
| Balıkesir University Medical Faculty Gastroenterology Dep. | Balıkesir | Turkey (Türkiye) |
| Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep. | Gaziantep | Turkey (Türkiye) |
| Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep. | Istanbul | Turkey (Türkiye) |
| Ümraniye Research and Training Hospital Gastroenterology Dep. | Istanbul | Turkey (Türkiye) |
| Ege University Medical Faculty Gastroenterology Dep. | Izmir | Turkey (Türkiye) |
| Tepecik Research and Training Hospital Gastroenterology Dep. | Izmir | Turkey (Türkiye) |
| Celal Bayar University Medical Faculty Gastroenterology Dep. | Manisa | Turkey (Türkiye) |
| Sıtkı Koçman University Medical Faculty Gastroenterology Dep. | Muğla | Turkey (Türkiye) |
| Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep. | Rize | Turkey (Türkiye) |
| Cumhuriyet University Medical Faculty Gastroenterology Dep. | Sivas | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
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