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

NCT02724150 | Withdrawn Phase 4 DMC

• 1 other identifier: G2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage

Keywords

Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage; Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• Mortality

  1 month

Secondary Outcomes (4)

• Rebleeding

  one month

• Surgery

  one month

• Length of hospital stay

  one month

• Blood transfusions

  one month

Study Arms (2)

Omeprazole High dose

ACTIVE COMPARATOR

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

Drug: Omeprazole High dose

Omeprazole Low Dose

EXPERIMENTAL

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

Drug: Omeprazole Low dose

Interventions

Omeprazole High dose DRUG

High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days

Omeprazole High dose

Omeprazole Low dose DRUG

low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days

Omeprazole Low Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Damascus Hospital: lead

Study Sites (1)

Damascus Hospital

Damascus, +963, Syria

Location

MeSH Terms

Conditions

Peptic Ulcer; Peptic Ulcer Hemorrhage

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marouf Alhalabi, MD

  Damascus Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 31, 2016
• Study Start: December 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

SY (1)