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

8. juli 2014 opdateret af: Yuhan Corporation

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: YH4808 A mg (Twice daily)
YH4808 A mg (Twice daily, Oral administration)
Medicin: YH4808 A mg
1 tablet = YH4808 A mg
Andre navne:
  • Uafklaret
Eksperimentel: YH4808 B mg (Once daily)
YH4808 B mg (Once daily, Oral administration)
Medicin: YH4808 B mg
1 tablet = YH4808 B mg
Andre navne:
  • Uafklaret
Eksperimentel: YH4808 B mg (Twice daily)
YH4808 B mg (Twice daily, Oral administration)
Medicin: YH4808 B mg
1 tablet = YH4808 B mg
Andre navne:
  • Uafklaret
Eksperimentel: YH4808 C mg (Once daily)
YH4808 C mg (Once daily, Oral administration)
Medicin: YH4808 C mg
YH4808 C mg = 2 x YH4808 B mg
Andre navne:
  • Uafklaret
Aktiv komparator: Esomeprazole 40mg (Once daily)
Esomeprazole 40mg (Once daily, Oral administration)
Medicin: Esomeprazole 40mg
1 tablet = Esomeprazole 40 mg
Andre navne:
  • Nexium

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Week 4
Week 4

Sekundære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Week 8
Week 8
Nocturnal Symptom Free Days & Symptom Free Days
Tidsramme: Treatment Period
Treatment Period
Sustained resolution of symptom & Time to first sustained symptom resolution
Tidsramme: Treatment Period
Treatment Period
Symptom Score
Tidsramme: Treatment Period
Treatment Period
Serum Gastrin Level
Tidsramme: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
Global Impression of Change (Patient, Investigator)
Tidsramme: Check at 4, and 8 weeks.
Check at 4, and 8 weeks.
Quality of Life
Tidsramme: Check at Baseline(Pre-dose), 4, and 8 weeks.
Check at Baseline(Pre-dose), 4, and 8 weeks.
Epworth Sleepiness Scale
Tidsramme: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
Check at Baseline(Pre-dose), 2, 4, and 8 weeks.

Andre resultatmål

Resultatmål
Tidsramme
Nocturnal Symptom Free Days & Symptom Free Days
Tidsramme: Follow-up period
Follow-up period
Sustained resolution of symptom
Tidsramme: Follow-up period
Follow-up period
Symptom Score
Tidsramme: Follow-up period
Follow-up period
Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)
Tidsramme: Check at Baseline, Week 4 and Week 8
Check at Baseline, Week 4 and Week 8
Healing Rate of Reflux Esophagitis and Symptom related endpoints by H.pylori positive or negative
Tidsramme: Treatement & Follow-up period
Treatement & Follow-up period
Adverse events, Physical examination results, ECG, Vital sign, Lab results
Tidsramme: Treatment & Follow-up period
Treatment & Follow-up period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yuhan Corporation

Efterforskere

  • Ledende efterforsker: Myung Gyy Choi, M.D., Ph.D., Catholic Univ. Seoul St. Mary Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

20. februar 2012

Først indsendt, der opfyldte QC-kriterier

23. februar 2012

Først opslået (Skøn)

24. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YH4808-201

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Refluksøsofagitis

Kliniske forsøg med YH4808 A mg

Søg i lignende forsøg

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Narkotikainterventioner

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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