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Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease (AGSPT)

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AGSPT201 Tab contains S-pantoprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, endoscopy, LA grade, heartburn

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

The Catholic University of Korea St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-Pantoprazole

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Absence and/or improvement of typical reflux symptoms

Patients recorded the improvement of typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation on diary card. The presence of symptoms are classified to absence (Score 0), mild (Score 1), moderate (Score 2), severe (Score 3) and very severe (Score 4).

Full Information

NCT ID

NCT01400945

First Posted

July 20, 2011

Last Updated

September 19, 2011

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01400945

Brief Title

Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Acronym

AGSPT

Official Title

Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

GERD, endoscopy, LA grade, heartburn

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

S-Pantoprazole

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AGSPT201 Tab contains S-pantoprazole

Other Intervention Name(s)

AGSPT201 Tab. (Brand name Deflux tab)

Intervention Description

comparison of Pantoloc Tab 40mg

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 week

Secondary Outcome Measure Information:

Title

Absence and/or improvement of typical reflux symptoms

Description

Time Frame

4 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials: