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Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01400945
First received: July 20, 2011
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Drug: AGSPT201 Tab contains S-pantoprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Number of patients with healing of erosive esophagitis(The absence of esophageal lesions) [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 154
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: AGSPT201 Tab. (Brand name Deflux tab)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400945

Locations
Korea, Republic of
The Catholic University of Korea St. Mary's Hospital
Seoul, Korea, Republic of, 137040
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01400945     History of Changes
Other Study ID Numbers: AGSPT P3
Study First Received: July 20, 2011
Last Updated: September 19, 2011
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
GERD
endoscopy
LA grade
heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013