Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

— AGSPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400945
• Other study ID #: AGSPT P3
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2011
• Last updated: September 19, 2011
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• AGSPT201 Tab contains S-pantoprazole
comparison of Pantoloc Tab 40mg

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes