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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: AGSPT201 Tab contains S-pantoprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137040
    • The Catholic University of Korea St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-Pantoprazole; Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole)	Drug: AGSPT201 Tab contains S-pantoprazole; comparison of Pantoloc Tab 40mg; Other Names: AGSPT201 Tab. (Brand name Deflux tab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 week

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: MyoungKyu Choi, M.D, The Catholic University of Korea-St. Mary's Hospital; Study Director: 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 record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): September 21, 2011
• Last Update Submitted That Met QC Criteria: September 19, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: GERD; endoscopy; heartburn; LA grade
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: AGSPT P3