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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01400945
First Posted: July 25, 2011
Last Update Posted: September 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahn-Gook Pharmaceuticals Co.,Ltd
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01400945     History of Changes
Other Study ID Numbers: AGSPT P3
First Submitted: July 20, 2011
First Posted: July 25, 2011
Last Update Posted: September 21, 2011
Last Verified: September 2011

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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action