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S-pantoprazole 10mg Phase III Clinical Study

Primary Purpose

Non Erosive Reflux Disease

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-pantoprazole 10mg
Placebo
Sponsored by
Ahn-Gook Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Erosive Reflux Disease

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Soon Chun Hyang University Hospital BucheonRecruiting
  • Bundang CHA Medical CenterRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • Seoul Metropolitan Government Seoul National University Boramae Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Seoul St. Mary's HospitalRecruiting
  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-pantoprazole 10mg

Placebo

Arm Description

S-pantoprazole 10mg Tablet once daily for 4 weeks

Placebo tablet for the test drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 13, 2014
Last Updated
October 24, 2014
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02274961
Brief Title
S-pantoprazole 10mg Phase III Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Erosive Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-pantoprazole 10mg
Arm Type
Experimental
Arm Description
S-pantoprazole 10mg Tablet once daily for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet for the test drug
Intervention Type
Drug
Intervention Name(s)
S-pantoprazole 10mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JINHYUNG KIM, Senior Researcher
Phone
82-2-3289-4362
Email
jhkim04@ahn-gook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chulhun Sung, Senior Researcher
Phone
82-2-3289-4284
Email
sch9013@ahn-gook.com
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Sung-Nam
State/Province
Gyeong-gi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ho Lee, Professor
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
GyeongGi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Jin Hong, Professor
Facility Name
Bundang CHA Medical Center
City
Sung-Nam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwang-Hyun Go, Professor
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-Hyung Lee, Professor
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hun-Yong Jung, Professor
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Jin Park, Professor
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Won Kim, Professor
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Gyun Kim, Professor
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JINHYUNG KIM
Phone
82-2-3289-4362
Email
jhkim04@ahn-gook.com
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Chan Lee, Professor

12. IPD Sharing Statement

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S-pantoprazole 10mg Phase III Clinical Study

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