S-pantoprazole 10mg Phase III Clinical Study

Non Erosive Reflux Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02274961
• Other study ID #: LTP10_KR_1301
• Status: Recruiting
• Phase: Phase 3
• First received: October 13, 2014
• Last updated: October 24, 2014
• Start date: October 2014

Study information

• Verified date: October 2014
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: JINHYUNG KIM, Senior Researcher
• Phone: 82-2-3289-4362
• Email: jhkim04[@]ahn-gook.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non Erosive Reflux Disease

Intervention

Drug:
• S-pantoprazole 10mg

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	GyeongGi-Do
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Bundang CHA Medical Center	Sung-Nam	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Sung-Nam	Gyeong-gi

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No