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

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ClinicalTrials.gov Identifier: NCT01039558
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : July 28, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Drug: ecabet sodium Drug: lansoprazole Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Study Start Date : December 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: lansoprazole + ecabet sodium 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.
Other Name: Gastrex ganules
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.
Placebo Comparator: lansoprazole + placebo 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.


Outcome Measures

Primary Outcome Measures :
  1. We will compare the summations of symptoms score and calculate the response rate [ Time Frame: after 4 weeks and 8 weeks ]

Secondary Outcome Measures :
  1. the global response of treatment [ Time Frame: after 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039558


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Joo Sung Kim, M.D., PhD Seoul National University Hospital
More Information

Responsible Party: Joo Sung Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01039558     History of Changes
Other Study ID Numbers: RECURRENT GERD
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
gastroesophageal reflux disease
lansoprazole
ecabet sodium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Dexlansoprazole
Ecabet
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Protease Inhibitors
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents