Efficacy of Low Dose of Proton Pump Inhibitor in Treatmen... | NCT03163680

Studies
Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers

NCT03163680

Sponsor

Damascus Hospital

Status

Completed

Last Update Posted

Jul 10, 2018Actual

Enrollment

295Actual

Phase

Not provided

Conditions

Gastroduodenal Ulcer
Marginal Ulcer
Peptic Ulcer Hemorrhage

Interventions

Omeprazole 40 MG

Countries

Syria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

Jun 4, 2018Actual

First Submitted Date

May 15, 2017

First Submission Date that Met QC Criteria

May 20, 2017

First Posted Date

May 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2018

Last Update Posted Date

Jul 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Detailed Description

Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

295Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose PPI		patients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily	Drug: Omeprazole 40 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omeprazole 40 MG	Drug	Omperazole 40 mg twice daily	Low Dose PPI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morality	Determination of mortality rate from ulcer bleeding	within 1 week

Secondary Outcomes

Measure	Description	Time Frame
Rebleeding	Determination of the percentage of the return of bleeding represented by recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment	within 1 week
need for surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to the gastrointestinal department of damascus hospital

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Damascus Hospital		Damascus		+963	Syria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010437	Peptic Ulcer
D010438	Peptic Ulcer Hemorrhage

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009853	Omeprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided