S-pantoprazole 10mg Phase III Clinical Study

Ahn-Gook Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Non Erosive Reflux Disease

Treatments: Drug: S-pantoprazole 10mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02274961

LTP10_KR_1301

Details and patient eligibility

About

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

Enrollment: 174 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 2 patient groups, including a placebo group

S-pantoprazole 10mg

Experimental group

Description:

S-pantoprazole 10mg Tablet once daily for 4 weeks

Treatment:

Drug: S-pantoprazole 10mg

Placebo

Placebo Comparator group

Description:

Placebo tablet for the test drug

Treatment:

Drug: Placebo