Study to Evaluate the Efficacy & Safety of Tegoprazan in ERD Patients With

Clinical Trial Description

This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg) ;

Study Design

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01797939` - Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients	N/A
	Completed	`NCT05267743` - Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease	Phase 4

See also

Status

Clinical Trial

Phase

Completed

NCT01797939 - Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

N/A

Completed

NCT05267743 - Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease

Phase 4

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04309916
Study type	Interventional
Source	HK inno.N Corporation
Contact
Status	Completed
Phase	Phase 4
Start date	May 22, 2020
Completion date	November 30, 2021

Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms