NCT01400945

Brief Summary

The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18\~75) with endoscopically proven GERD treated with AGSPT201 Tablet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P25-P50 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

July 20, 2011

Last Update Submit

September 19, 2011

Conditions

Gastroesophageal Reflux Disease

Keywords

GERDendoscopyLA gradeheartburn

Outcome Measures

Primary Outcomes (1)

  • Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)

    Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions.

    4 week

Secondary Outcomes (1)

  • Absence and/or improvement of typical reflux symptoms

    4 week

Study Arms (1)

S-Pantoprazole

EXPERIMENTAL

Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole)

Drug: AGSPT201 Tab contains S-pantoprazole

Interventions

AGSPT201 Tab contains S-pantoprazoleDRUG

comparison of Pantoloc Tab 40mg

Also known as: AGSPT201 Tab. (Brand name Deflux tab)
S-Pantoprazole

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18\~75 years
  • Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification)
  • Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month
  • Symptoms on at least 2 days of the past 7 days

You may not qualify if:

  • PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing.
  • Patients whose history of GI tract resection or vagotomy.
  • Barrett's oesophagus greater than 3cm in length and high-grade dysplasia.
  • Acid irrelevant Heartburn and regurgitation.
  • Zollinger Ellison syndrome
  • Hypersensitive and/or allergy to Pantoprazole and/or other PPI
  • Pregnancy and lactation
  • peptic ulcer
  • serious hepatic
  • any other renal, cardiac or haematological disease.
  • Patients participated any other clinical studies during the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea St. Mary's Hospital

Seoul, Seoul, 137040, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MyoungKyu Choi, M.D

    The Catholic University of Korea-St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

  • YoungTae Park, M.D.

    Korea University Medical Center-Guro

    STUDY DIRECTOR

  • PoongRyul Lee, M.D

    Samsung Medical Center

    STUDY DIRECTOR

  • SangKyun Kim, M.D

    Seoul National University Hospital

    STUDY DIRECTOR

  • HoonYong Jeong, M.D

    Asan Medical Center

    STUDY DIRECTOR

  • SangYoung Seol, M.D

    Inje University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 25, 2011

Study Start

December 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

KR(1)