Gastroduodenal UlcerNCT03163680
Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers
An observational study of Gastroduodenal Ulcer and Marginal Ulcer, run by Damascus Hospital at 1 site in Syria.
Trial summary
Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage
- What is being tested?
- Omeprazole 40 MG
- How many people
- 295 participants
- Where
- 1 siteSyria
- Study dates
- Jan 2012to 4 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to the gastrointestinal department of damascus hospital
Who may be able to join
- 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).
Who cannot join
- ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Low Dose of Proton Pumb Inhabitor in Treatment Upper Gastrointestinal Bleeding
Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding
Read the detailed description
Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding
- Being tested
- Omeprazole 40 MG
- Keywords
- Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer
- Medical subject headings
- Peptic Ulcer, Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 40 MGDrug
Omperazole 40 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Low Dose PPI | patients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily Receives: Drug: Omeprazole 40 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morality
Determination of mortality rate from ulcer bleeding
Measured: within 1 week
Secondary outcomes (4)
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
Measured: within 1 week
need for surgery
Determine the Surgery rate for treatment Bleeding ulcers within a week
Measured: within 1 week
Length of hospital stay
Determining the length of stay in the hospital
Measured: within 1 month
Blood transfusions
number of transfusion blood unites during admission
Measured: within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startJan 2012
- Primary completion1 May 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroduodenal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marouf Alhalabi, Damascus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163680
- Sponsor's protocol ID
- G6-17
- Status last verified
- Jul 2018
- First submitted
- 15 May 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose of Proton Pumb Inhabitor in Treatment Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT03163680
- Acronym / sponsor ID
- G6-17
- Keywords
- Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Damascus HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose PPI | – | Drug: Omeprazole 40 MGpatients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the gastrointestinal department of damascus hospital
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole 40 MGOmperazole 40 mg twice daily | Drug | Low Dose PPI |
Primary outcome
Morality
Time frame: within 1 week
Determination of mortality rate from ulcer bleeding
4 secondary outcomes
Rebleeding
Time frame: within 1 week
need for surgery
Time frame: within 1 week
Length of hospital stay
Time frame: within 1 month
Blood transfusions
Time frame: within 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroduodenal Ulcer and Marginal Ulcer, run by Damascus Hospital at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morality (time frame: within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.