Back to resultsThe Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ecabet sodium
lansoprazole
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring gastroesophageal reflux disease, lansoprazole, ecabet sodium
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
lansoprazole + ecabet sodium
lansoprazole + placebo
Arm Description
Outcomes
Primary Outcome Measures
We will compare the summations of symptoms score and calculate the response rate
Secondary Outcome Measures
the global response of treatment
Full Information
NCT ID
NCT01039558
First Posted
December 23, 2009
Last Updated
July 27, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01039558
Brief Title
The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Official Title
Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
gastroesophageal reflux disease, lansoprazole, ecabet sodium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lansoprazole + ecabet sodium
Arm Type
Active Comparator
Arm Title
lansoprazole + placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ecabet sodium
Other Intervention Name(s)
Gastrex ganules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
lansoprazole
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
We will compare the summations of symptoms score and calculate the response rate
Time Frame
after 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
the global response of treatment
Time Frame
after 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Sung Kim, M.D., PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
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