The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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We will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal reflux disease.

Official Title
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Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: ecabet sodium
* Drug: lansoprazole
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 19-75 years patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more Exclusion Criteria: patients with gastric ulcer or duodenal ulcer patients with gastric cancer or esophageal cancer pregnant or postpartum women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lansoprazole + ecabet sodium<br> | Drug: ecabet sodium<br>* Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.<br>* Other names: Gastrex ganules;Drug: lansoprazole<br>* Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.<br>|
| Placebo Comparator: lansoprazole + placebo<br> | Drug: lansoprazole<br>* Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.<br>Drug: placebo<br>* Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will compare the summations of symptoms score and calculate the response rate |  | after 4 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the global response of treatment |  | after 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroesophageal reflux disease, lansoprazole, ecabet sodium