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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01039558
First received: December 23, 2009
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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 Intervention
Gastroesophageal Reflux Disease
Drug: ecabet sodium
Drug: lansoprazole
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • We will compare the summations of symptoms score and calculate the response rate [ Time Frame: after 4 weeks and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the global response of treatment [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Joo Sung Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01039558     History of Changes
Other Study ID Numbers: RECURRENT GERD
Study First Received: December 23, 2009
Last Updated: July 27, 2011
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014