Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding

Damascus Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Peptic Ulcer Hemorrhage; Marginal Ulcer; Gastroduodenal Ulcer

Treatments: Drug: Omeprazole High dose; Drug: Omeprazole Low dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02724150

G2

Details and patient eligibility

About

Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding

Full description

Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata,
• active bleeding was defined as a continuous blood spurting (Forrest IA)
• oozing (Forrest IB) from the ulcer base.
• A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).
• An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion criteria

• ulcer was malignant
• non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Omeprazole High dose

Active Comparator group

Description:

Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days

Treatment:

Drug: Omeprazole High dose

Omeprazole Low Dose

Experimental group

Description:

Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days

Treatment:

Drug: Omeprazole Low dose