- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00519519
Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Introduction
Peptic ulcer bleeding (PUB) is a common and life threatening condition. Intravenous infusion of high dose omeprazole (80mg as bolus followed by 8 mg/hr for 72 hours ie 652 mg/72 hrs) after endoscopic therapy resulted in greater reductions of re-bleeding than did placebo. Thus the above regime became our departmental protocol. However, there is some evidence that both high dose and a regular dose of omeprazole (40mg once a day followed by a saline infusion ie 120mg/72 hrs) would be equally effective. We calculated that high dose regimen is about S$ 500 more expensive. The aim of our study is to determine the equivalence of both regimes in preventing re-bleeding rate (primary end-point), surgery and mortality in PUB patients.
Study design This is a single institution prospective randomized double-blind study. All patient with PUB (Forrest classification I, IIa and IIb: spurting or oozing bleeding, visible vessels and clot) had endoscopic treatments (adrenaline injection and/or heater probe). After successful endoscopic hemostasis, patients are randomized to receive a high or regular dose of omeprazole infusion. After 72 hours, both groups of patients are given oral omeprazole 40mg daily for 4 weeks. All patients are evaluated at the clinic at the end of 4 weeks. The primary end-point is rebleeding. Other secondary endpoints measured are surgery, duration of hospital stay and death.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Outram Road
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Outram Road, Singapore, Outram Road, Singapore, 169608
- Singapore General Hospital
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Singapore, Outram Road, Singapore, 169608
- Singapore General Hospital
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-
Outram road
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Outram Road, Singapore, Outram road, Singapore, 169608
- Department of Surgery, Singapore General Hospital
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Singapore, Outram road, Singapore, 169608
- Department of Surgery, Singapore General Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Above 21 year old
- OGD done within 48 hrs of admission
- No recent upper GIT surgery past one month
- Forrest Type I, IIa & IIb ulcer (Type Ia: Spurting, Ib:Oozing, IIa: Visible vessel, IIb: Clot)
- Non-malignant ulcer
- Informed consent taken
Exclusion Criteria:
- Impaired hepatic function
- Pregnancy
- Lactation
- Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin)
- Underlying malignancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 2
regular dose versus high dose
|
intravenous 80mg bolus followed by 8mg / hr for 3 days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
Tidsramme: 30 days after endoscopic therapy
|
30 days after endoscopic therapy
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Surgery, Death and Length of hospital stay
Tidsramme: 30 days after endoscopic thearpy
|
30 days after endoscopic thearpy
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Weng Hoong Chan, MBBS, FRCS, Singapore General Hospital
- Ledende efterforsker: Weng Hoong Chan, MBBS, FRCS, Department of Surgery, Singapore General Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Gastrointestinale sygdomme
- Mavesygdomme
- Tarmsygdomme
- Duodenale sygdomme
- Gastrointestinal blødning
- Mavesår
- Blødning
- Mavesår
- Mavesår blødning
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Gastrointestinale midler
- Anti-ulcus midler
- Protonpumpehæmmere
- Omeprazol
Andre undersøgelses-id-numre
- 78:10/03-098
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 .
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