NCT01039558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

December 23, 2009

Last Update Submit

July 27, 2011

Conditions

Gastroesophageal Reflux Disease

Keywords

gastroesophageal reflux diseaselansoprazoleecabet sodium

Outcome Measures

Primary Outcomes (1)

  • We will compare the summations of symptoms score and calculate the response rate

    after 4 weeks and 8 weeks

Secondary Outcomes (1)

  • the global response of treatment

    after 8 weeks

Study Arms (2)

lansoprazole + ecabet sodium

ACTIVE COMPARATOR
Drug: ecabet sodiumDrug: lansoprazole

lansoprazole + placebo

PLACEBO COMPARATOR
Drug: lansoprazoleDrug: placebo

Interventions

ecabet sodiumDRUG

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.

Also known as: Gastrex ganules
lansoprazole + ecabet sodium
lansoprazoleDRUG

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 + ecabet sodiumlansoprazole + placebo
placeboDRUG

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

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with gastric ulcer or duodenal ulcer
  • patients with gastric cancer or esophageal cancer
  • pregnant or postpartum women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

ecabetLansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Joo Sung Kim, M.D., PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations

KR(1)