The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
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.
Full Title of Study: “Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: March 2011
Interventions
- Drug: ecabet sodium
- 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.
- Drug: lansoprazole
- 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.
- Drug: placebo
- 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.
Arms, Groups and Cohorts
- Active Comparator: lansoprazole + ecabet sodium
- Placebo Comparator: lansoprazole + placebo
Clinical Trial Outcome Measures
Primary Measures
- We will compare the summations of symptoms score and calculate the response rate
- Time Frame: after 4 weeks and 8 weeks
Secondary Measures
- the global response of treatment
- Time Frame: after 8 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Seoul National University Hospital
- Provider of Information About this Clinical Study
- Joo Sung Kim, Seoul National University Hospital
- Overall Official(s)
- Joo Sung Kim, M.D., PhD, Principal Investigator, Seoul National University Hospital
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.