A Clinical Trial for the evaluation of the efficacy and safety of RW0117 on dyspepsia

A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the evaluation of the efficacy and safety of RW0117 on dyspepsia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005265

Enrollment

100

Registered

2020-07-28

Start date

2019-09-23

Completion date

Unknown

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : Subjects are randomly assigned to either the test group or the control group according to the registered order. Subjects take investigational produc Investigational product(RW0117): once a da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) ?? 6?? ??? ??? ????, ??? ??(???, ??? ?), ?? ??(???, ????, ???, ??? ??? ?? ???) ?? ??? ?? ? (?, ????? ??? ?????? ???? ??? ??? ??? ?? ??? ??? ? ??.) 2) 6?? ??? ??? ?? ? ??? ??? ?? ??? ?? ? 3) ??? ???? ?? ?(??????? ? ????? ??) 4) ???? ????? ??? ?? ?? 5) ??1 ?? 2? ??? H2 ??? ???, ????(???? ??? ???), ???? ??? ???, ??????? ??, ??? ?? ???, ??????, ?? ?? ?? ??? ??, ? ?? ??????? ??? ? 6) ?????? ?? ?? ????????, ??????? ???, ???? ? ??? ???? ? ?? ??? ????? ???? ?? ? 7) ?? ?? ???? ?? 1?? ?? 1??? ?? ?? 14unit, ?? 7unit ??? ??? ?? ??? ?? ? 8) ???? ?? ??? ??(??? ?? 160mmHg ?? ?? ??? ?? 100mmHg ??, ?????? ??? 10? ?? ? ????) 9) ??? ???? ?? ??? ?? (?? ??? 180mg/dl ??) 10) Creatinine? ???? ?? ???? 2? ?? ? 11) AST(GOT) ?? ALT(GPT)? ???? ?? ???? 3? ??? ? 12) TSH? 0.1 µIU/ml ????? 10 µIU/ml ??? ? 13) ? ??????? ??? ????? ????? ?? ? 14) ?? ???? ?? ? ?? 3?? ??? ??? ???? ?? ? 15) 1?? ??? ?? ??????? ??????, ? ?????? ?? ?? ?? ??????? ??? ??? ?? ? 16) ???? ? ??????? ?????? ???? ? 17) ??? ???(????) ? ????????? ????? ???

Exclusion criteria

Exclusion criteria: 1) Patients with a history of severe malignant tumors, cerebrovascular disease (cerebroinfarction, brain hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the past 6 months (but clinically In the case of a stable human-applied test subject, the tester can participate in the test.) 2) Persons with a history of peptic ulcer and reflux esophagitis within 6 months 3) Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy) 4) Patients with a history of malignancy of the digestive system 5) Those who have taken H2 receptor blockers, anticholinergic drugs (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosal protective agents, other drugs intended to treat gastritis, gastric health functional food within 2 weeks of Visit 1 6) Those who need to continuously take drugs that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti-inflammatory drugs, aspirin, etc. 7) In the drinking habit questionnaire, those who had an average alcohol consumption habit of 14 units or more for men and 7 units per week for the past month. 8) Uncontrolled hypertension patients (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement standard after 10 minutes of human body test) 9) Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg/dL) e is more than twice the normal upper limit of the test institution 11) Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution 12) TSH of 0.1 µIU/ml or less or 10 µIU/ml or more 13) Persons who are sensitive or allergic to investigational product for this clinical trial 14) Pregnant, lactating or planning to become pregnant within 3 months 15) Those who participated in other clinical trials within 3 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trials. 16) A person who determines that the Investigator is inappropriate for clinical trials 17) Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital

Design outcomes

Primary

Measure	Time frame
GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score	—

Secondary

Measure	Time frame
GSRS(Gastrointestinal Symptom Rating Scale) Total score;GIS(Gastrointestinal Symptom);NDI-K(Nepean dyspepsia index-Korean);FD-QoL (Functional Dyspepsia-Related Quality of Life);ESR(Erythrocyte Sedimentation Rate), CRP(C-Reactive Protein);GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score	—

Countries

Korea, Republic of

Contacts

Public ContactDONGHO LEE

Seoul National University Bundang Hospital

Outcome results