The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease - Full Text View

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:

MedlinePlus related topics: GERD

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

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.

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

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
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Ecabet
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013