Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).
Objectives of the trial to assess the efficacy of lansoprazole in combination with domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics and gastric emptying in patients with GERD.
24 hour pH measurement and gastric emptying test will be done at screening visit and after 7 days of drug treatment. Twelve patients will take one tablet for 7 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole/Domperidone | Experimental | DUOLANS 30/30 mg SR tablet per oral, one tablet daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole/Domperidone | Drug | DUOLANS 30/30 mg SR tablet per oral, one tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage time of 24-hour intragastric pH >4 compared to baseline | 7 days | |
| The AUC of 24-hour intragastric pH >4 compared to baseline | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The significant increase in total measurements of median pH | 7 days | |
| The significant increase in nocturnal measurements of median pH | 7 days | |
| The decrease in reflux symptom index calculated by weekly regurgitation numbers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neutec Ar-Ge San ve Tic A.S | Neutec Ar-Ge Clinical Trial | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey | Izmir | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 7 days |
| The decrease in reflux symptom index calculated by weekly pyrosis numbers | 7 days |
| The percentage time of 24-hour intragastric pH >2 compared to baseline | 7 days |
| The percentage time of 24-hour intragastric pH >6 compared to baseline | 7 days |
| The AUC of 24-hour intragastric pH >2 compared to baseline | 7 days |
| The AUC of 24-hour intragastric pH >6 compared to baseline | 7 days |
| The percentage time of 24-hour total intragastric pH >4 compared to baseline | 7 days |
| The AUC of 24-hour total intragastric pH >4 compared to baseline | 7 days |
| The evaluation of gastric emptying by octanoic acid breath test compared to baseline | 7 days |
| The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment) | 7 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 |
| D010880 | Piperidines |