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

Seoul National University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

ecabet sodiumDRUG

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.

lansoprazoleDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

We will compare the summations of symptoms score and calculate the response rate

Time frame: after 4 weeks and 8 weeks

Secondary Outcomes

the global response of treatment

Time frame: after 8 weeks

Data from ClinicalTrials.gov

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