Comparison of effects of Tegoprazan and Mucosta combination therapy and Tegoprazan monotherapy on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding for iatrogenic ulcers after Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer

Comparison of effects of Tegoprazan and Mucosta combination therapy and Tegoprazan monotherapy on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding for iatrogenic ulcers after Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer: A Multicenter, Randomized, Parallel and Prospective study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007063

Enrollment

140

Registered

2022-03-08

Start date

2022-04-04

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

None listed

Interventions

Drug : Enrolled patients will assigned to either the tegoprazan 50 mg and rebamipide combination therapy group or the tegoprazan 50 mg monotherapy group to receive treatment for up to 8 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Male or female subjects =19 and <85 years of age ? Patients undergoing endoscopic submucosal dissection for gastric adenoma or early gastric cancer with a resected tissue having a length of at least 2 cm ? Patients who agreed to participate in the study and voluntarily signed a written informed consent form

Exclusion criteria

Exclusion criteria: ? Hypersensitivity to the IMP ? Use of prohibited drugs (such as atazanavir) for combination with the IMP ? Laboratory abnormalities, as listed below - Total bilirubin or creatinine >1.5x institutional upper limit of normal (ULN) - AST, ALT, alkaline phosphatase, BUN >2x institutional ULN ? Diagnosis of cancer other than gastric cancer in the last 5 years ? History of the following diseases: Zollinger-Ellison syndrome, Barrett' s esophagus, primary esophageal motility disorder, esophageal stenosis, pancreatitis, malabsorption, or severe cardiovascular or pulmonary disease ? Patients who have undergone a major surgery that may affect gastric acid secretion ? Patients who are unable to discontinue the following drugs until the end of the study (for 8 weeks): warfarin, clopidogrel, direct oral anticoagulant, steroid, NSAIDs drug anticholinergics, prostaglandin analogs, sucralfate, and aspirin ? Serious organ failure (such as hepatic or renal dysfunction) ? Pregnant or breastfeeding women ? Experience of participating in other clinical trials within 30 days prior to screening ? Other patients that the investigator considers ineligible for this study

Design outcomes

Primary

Measure	Time frame
Efficacy Endpoints	—

Secondary

Measure	Time frame
Efficacy Endpoints	—

Countries

Korea, Republic of

Contacts

Public ContactTaewan Kim

Kangdong Sacred Heart Hospital

attack836@naver.com+82-2-2224-2562

Outcome results