S-pantoprazole 10mg Phase III Clinical Study

Phase 3

• Conditions: Non Erosive Reflux Disease
• Interventions: Drug: Placebo; Drug: S-pantoprazole 10mg

• Registration Number: NCT02274961
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-24
• Last Update Submitted: 2014-10-24
• Study First Posted: 2014-10-27
• Last Update Posted: 2014-10-27
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet for the test drug
S-pantoprazole 10mg	S-pantoprazole 10mg	S-pantoprazole 10mg Tablet once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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	4 weeks

Trial Locations

Locations (10)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Bundang CHA Medical Center; 🇰🇷 Sung-Nam, Gyeonggi-do, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, GyeongGi-Do, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Sung-Nam, Gyeong-gi, Korea, Republic of

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of