Clinical trial NCT02274961: S-pantoprazole 10mg Phase III Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non Erosive Reflux Disease
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 174
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sung-Nam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeong-gi
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: GyeongGi-Do
city: Sung-Nam
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: