Evaluation of Efficacy of Ilaprazole Administration on Patients with NERD

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0004463
• Lead Sponsor: Kangwon National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

? Subjects showing heartburn or acid reflux symptom within recent six months before screening day (visit 1) with typical GERD symptoms.
? Subjects who show either heartburn or acid reflux symptom more than mild level seven days, at least two days, before screening day (visit 1) or have serious acid reflux symptom for more than a day.
? Subjects whose GERD Q score is more than eight..
? Mucosal breaks should not be found by Endoscopy conducted within one month before clinical trial start date (visit2) according to LA classification.

Exclusion Criteria

?Known hypersensitivity to experimental or PPI drug
?Subjects who are taking contraindicated medications for experimental drug
?Subjects with abnormal levels in the laboratory tests
Total Bilirubin, Creatinine> 1.5 times upper limit of normal
Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)> 2 times upper limit of normal
? Subjects who took PPI products within 4 weeks or H2RA within one week before experimental drug administration
? Pregnant and/or lactating women
? A woman who does not use medically acceptable contraception during the clinical trial (Menopausal women who are at least 12 months of amenorrhea are considered to be non-working women)
? Uncontrolled liver dysfunction
? Subjects with gastrointestinal bleeding symptom or ulcer on esophagus, stomach, duodenum
? Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, Upper gastrointestinal malignant disease, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
? Subjects taking anticholinergics, promotility agents, prostaglandin analogs, sucralfate, more than 165mg salicylate, steroid, NSAIDs drug regularly
? Subjects who participated in other clinical trial 30 days before starting this clinical trial
? Patients whom other researchers deemed inappropriate for participation in clinical trials

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oss of heartburn symptoms for 7 consecutive days

Secondary Outcome Measures

Name	Time	Method
The rate of days heartburn-free for 4 weeks;Percentage of patients who lost heartburn symptoms for 7 consecutive days;Evaluation of Gastrointestinal Symptom Rating Scale (GSRS)