Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis

Reflux Esophagitis Clinical Trial

Official title:

Randomized, Double-blind, Active-controlled, Multi-center Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538849
• Other study ID #: YH4808-201
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2012
• Last updated: July 8, 2014
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This study is to investigate the optimal clinical dose and administration methods of YH4808 in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral administration.

Description:

In the result of recent meta-analysis, there was no improvement in symptoms with the first administration of PPI in about 75% of GERD patients, and symptoms were still sustained in about 50% of patients after administration of more than 3 days. Especially the nocturnal secretion of gastric acid was not effectively inhibited, and about 25% of GERD patients could not achieve the proper therapeutic effects even after PPI treatment twice daily for 4-8 weeks.

YH4808, as a selective K+- competitive acid blocker (P-CAB), is no need for activation by gastric acid since it competitively inhibits proton pump with K+. Thus, the inhibition of gastric acid secretion by YH4808 is prompt and effective. In addition, the inhibitive effect of gastric acid secretion by stimulation of histamine is proved to be more powerful than PPI (esomeprazole) and sustained in in-vitro/in-vivo model, and 24-h inhibition of gastric acid secretion and especially nocturnal inhibition of gastric acid secretion was observed to be superior to esomeprazole with repeat doses for 7 days in healthy volunteers.

Based on these nonclinical and clinical outcomes, an exploratory phase-II clinical trial is to be conducted to determine the proper treatment dose and administration method of YH48084 for GERD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Subject who has signed on the written consent

2. Male and female aged 20 and over

3. Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 2 weeks before randomisation

Exclusion Criteria:

1. History or presence of upper gastrointestinal anatomic or motor disorders

2. Other exclusions apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Reflux Esophagitis

Intervention

Drug:
• Esomeprazole 40mg
1 tablet = Esomeprazole 40 mg
• YH4808 A mg
1 tablet = YH4808 A mg
• YH4808 B mg
1 tablet = YH4808 B mg
• YH4808 C mg
YH4808 C mg = 2 x YH4808 B mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul ST.MARY'S HOSPITAL	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nocturnal Symptom Free Days & Symptom Free Days		Follow-up period	No
Other	Sustained resolution of symptom		Follow-up period	No
Other	Symptom Score		Follow-up period	No
Other	Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)		Check at Baseline, Week 4 and Week 8	No
Other	Healing Rate of Reflux Esophagitis and Symptom related endpoints by H.pylori positive or negative		Treatement & Follow-up period	No
Other	Adverse events, Physical examination results, ECG, Vital sign, Lab results		Treatment & Follow-up period	No
Primary	Number of Participants With Healing of Reflux Esophagitis (RE) Who Were "Normal(including minimal change)" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification		Week 4	No
Secondary	Number of Participants With Healing of Reflux Esophagitis (RE) Who Were "Normal(including minimal change)" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification		Week 8	No
Secondary	Nocturnal Symptom Free Days & Symptom Free Days		Treatment Period	No
Secondary	Sustained resolution of symptom & Time to first sustained symptom resolution		Treatment Period	No
Secondary	Symptom Score		Treatment Period	No
Secondary	Serum Gastrin Level		Check at Baseline(Pre-dose), 2, 4, and 8 weeks.	No
Secondary	Global Impression of Change (Patient, Investigator)		Check at 4, and 8 weeks.	No
Secondary	Quality of Life		Check at Baseline(Pre-dose), 4, and 8 weeks.	No
Secondary	Epworth Sleepiness Scale		Check at Baseline(Pre-dose), 2, 4, and 8 weeks.	No