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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02724150 |
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Date of registration:
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14/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
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Scientific title:
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Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding |
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Date of first enrolment:
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December 1, 2017 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02724150 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Syrian Arab Republic
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Contacts
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Name:
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Marouf Alhalabi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Damascus Hospital |
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Key inclusion & exclusion criteria
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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....
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastroduodenal Ulcer
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Marginal Ulcer
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Peptic Ulcer Hemorrhage
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Intervention(s)
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Drug: Omeprazole High dose
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Drug: Omeprazole Low dose
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Primary Outcome(s)
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Mortality
[Time Frame: 1 month]
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Secondary Outcome(s)
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Blood transfusions
[Time Frame: one month]
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Rebleeding
[Time Frame: one month]
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Length of hospital stay
[Time Frame: one month]
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Surgery
[Time Frame: one month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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