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NCT Number: NCT01538849

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

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.

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Key information

Conditions

Reflux Esophagitis Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul ST.MARY'S HOSPITAL

Seoul, 137-701, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject who has signed on the written consent
  • Male and female aged 20 and over
  • Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 2 weeks before randomisation

Exclusion criteria

  • History or presence of upper gastrointestinal anatomic or motor disorders
  • Other exclusions apply.

Treatment and study plan

Esomeprazole 40mg

Drug

1 tablet = Esomeprazole 40 mg

Other names: Nexium

YH4808 A mg

Drug

1 tablet = YH4808 A mg

Other names: Undecided

YH4808 B mg

Drug

1 tablet = YH4808 B mg

Other names: Undecided

YH4808 C mg

Drug

YH4808 C mg = 2 x YH4808 B mg

Other names: Undecided

Primary outcomes

  1. 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

    Time frame: Week 4

Secondary outcomes

  1. 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

    Time frame: Week 8

  2. Nocturnal Symptom Free Days & Symptom Free Days

    Time frame: Treatment Period

  3. Sustained resolution of symptom & Time to first sustained symptom resolution

    Time frame: Treatment Period

  4. Symptom Score

    Time frame: Treatment Period

  5. Serum Gastrin Level

    Time frame: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.

  6. Global Impression of Change (Patient, Investigator)

    Time frame: Check at 4, and 8 weeks.

  7. Quality of Life

    Time frame: Check at Baseline(Pre-dose), 4, and 8 weeks.

  8. Epworth Sleepiness Scale

    Time frame: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.

Other outcomes

  1. Nocturnal Symptom Free Days & Symptom Free Days

    Time frame: Follow-up period

  2. Sustained resolution of symptom

    Time frame: Follow-up period

  3. Symptom Score

    Time frame: Follow-up period

  4. Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)

    Time frame: Check at Baseline, Week 4 and Week 8

  5. Healing Rate of Reflux Esophagitis and Symptom related endpoints by H.pylori positive or negative

    Time frame: Treatement & Follow-up period

  6. Adverse events, Physical examination results, ECG, Vital sign, Lab results

    Time frame: Treatment & Follow-up period

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 24, 2012
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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