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Completed

NCT Number: NCT01400945

Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Catholic University of Korea St. Mary's Hospital

Seoul, 137040, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGSPT201 Tab contains S-pantoprazole

Drug

comparison of Pantoloc Tab 40mg

Other names: AGSPT201 Tab. (Brand name Deflux tab)

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Acronym: AGSPT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Sep 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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