Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: AGSPT201 Tab contains S-pantoprazole

• Registration Number: NCT01400945
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2011-08
• Status Verified: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-19
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-Pantoprazole	AGSPT201 Tab contains S-pantoprazole	Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole)

Primary Outcome Measures

Name	Time	Method
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)	4 week	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

Name	Time	Method
Absence and/or improvement of typical reflux symptoms	4 week	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).

Trial Locations

Locations (1)

The Catholic University of Korea St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of