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

NCT ID: NCT01039558

Last Updated: 2011-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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lansoprazole + ecabet sodium

Group Type ACTIVE_COMPARATOR

ecabet sodium

Intervention Type DRUG

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.

lansoprazole

Intervention Type DRUG

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.

lansoprazole + placebo

Group Type PLACEBO_COMPARATOR

lansoprazole

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Gastrex ganules

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Joo Sung Kim, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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RECURRENT GERD

Identifier Type: -

Identifier Source: org_study_id

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