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Reflux EsophagitisPhase 2NCT01538849

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

A Phase 2 study testing Esomeprazole 40mg, YH4808 A mg and YH4808 B mg in people with Reflux Esophagitis, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Reflux Esophagitis
What is being tested?
Esomeprazole 40mg, YH4808 A mg and YH4808 B mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteSouth Korea
Study dates
Dec 2012to May 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul ST.MARY'S HOSPITAL

    Seoul, 137-701

Other trials in South Korea

About this study

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

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.

Read the detailed 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.

Being tested
Esomeprazole 40mg, YH4808 A mg, YH4808 B mg, YH4808 C mg
Medical subject headings
Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esomeprazole 40mgDrug

    Also called Nexium

    1 tablet = Esomeprazole 40 mg

  • YH4808 A mgDrug

    Also called Undecided

    1 tablet = YH4808 A mg

  • YH4808 B mgDrug

    Also called Undecided

    1 tablet = YH4808 B mg

  • YH4808 C mgDrug

    Also called Undecided

    YH4808 C mg = 2 x YH4808 B mg

Study groups in NCT01538849
Study groupRoleWhat they receive
YH4808 A mg (Twice daily)ExperimentalYH4808 A mg (Twice daily, Oral administration)
Receives: Drug: YH4808 A mg
YH4808 B mg (Once daily)ExperimentalYH4808 B mg (Once daily, Oral administration)
Receives: Drug: YH4808 B mg
YH4808 B mg (Twice daily)ExperimentalYH4808 B mg (Twice daily, Oral administration)
Receives: Drug: YH4808 B mg
YH4808 C mg (Once daily)ExperimentalYH4808 C mg (Once daily, Oral administration)
Receives: Drug: YH4808 C mg
Esomeprazole 40mg (Once daily)Active comparatorEsomeprazole 40mg (Once daily, Oral administration)
Receives: Drug: Esomeprazole 40mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 4

Secondary outcomes (8)

  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

    Measured: Week 8

  2. Nocturnal Symptom Free Days & Symptom Free Days

    Measured: Treatment Period

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

    Measured: Treatment Period

  4. Symptom Score

    Measured: Treatment Period

  5. Serum Gastrin Level

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

  6. Global Impression of Change (Patient, Investigator)

    Measured: Check at 4, and 8 weeks.

  7. Quality of Life

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

  8. Epworth Sleepiness Scale

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538849
Sponsor's protocol ID
YH4808-201
Status last verified
Jul 2014
First submitted
20 Feb 2012
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Esomeprazole 40mg, YH4808 A mg and YH4808 B mg in people with Reflux Esophagitis, run by Yuhan Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01538849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.

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