S-pantoprazole 10mg Phase III Clinical Study

October 24, 2014 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Si-Hyung Lee, Professor
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Hun-Yong Jung, Professor
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Sang-Gyun Kim, Professor
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Hyo-Jin Park, Professor
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
          • Yong-Chan Lee, Professor
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
        • Contact:
          • Ji-Won Kim, Professor
    • Gyeong-gi
      • Sung-Nam, Gyeong-gi, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Dong-Ho Lee, Professor
    • GyeongGi-Do
      • Bucheon, GyeongGi-Do, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
          • Su-Jin Hong, Professor
    • Gyeonggi-do
      • Sung-Nam, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Bundang CHA Medical Center
        • Contact:
          • Gwang-Hyun Go, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults between the ages of 19 and 75 inclusive
  • Patient with a history of heartburn or acid regurgitation for at least 3 months.
  • Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline
  • Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening
  • Capable of providing written informed consent, willing and able to a comply with all procedures of the study

Exclusion Criteria:

  • History of endoscopic erosive esophagitis(EE) at screening EGD.
  • Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
  • More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
  • Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
  • H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening
  • Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease,
  • Known hypersensitivity to any component of drug
  • pregnancy or lactation (F only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-pantoprazole 10mg
S-pantoprazole 10mg Tablet once daily for 4 weeks
Drug: S-pantoprazole 10mg
Placebo Comparator: Placebo
Placebo tablet for the test drug
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

October 13, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 24, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTP10_KR_1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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