Gastroduodenal UlcerPhase 4NCT02724150
Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
A Phase 4 study testing Omeprazole High dose and Omeprazole Low dose in people with Gastroduodenal Ulcer and Marginal Ulcer, run by Damascus Hospital at 1 site in Syria.
Trial summary
Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage
- What is being tested?
- Omeprazole High dose and Omeprazole Low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2017to Jul 2021
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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: Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding
Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding
Read the detailed 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
- Being tested
- Omeprazole High dose, Omeprazole Low dose
- 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 High doseDrug
High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days
Omeprazole Low doseDrug
low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole High dose | Active comparator | Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days Receives: 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 Receives: Drug: Omeprazole Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 month
Secondary outcomes (4)
Rebleeding
recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment
Measured: one month
Surgery
need for surgery
Measured: one month
Length of hospital stay
Measured: one month
Blood transfusions
number of transfusion blood unites during admission
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start1 Dec 2017
- Primary completionFeb 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: No participants enrolled
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marouf Alhalabi, MD, Principal investigator, Damascus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724150
- Sponsor's protocol ID
- G2
- Status last verified
- Jul 2018
- First submitted
- 14 Mar 2016
- 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
- Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT02724150
- Acronym / sponsor ID
- G2
- Keywords
- Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Damascus HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- 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.
Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole High dose | Active comparator | Drug: Omeprazole High doseOmeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days |
| Omeprazole Low Dose | Experimental | Drug: Omeprazole Low doseOmeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 (2 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 High doseHigh regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days | Drug | Omeprazole High dose |
| Omeprazole Low doselow regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days | Drug | Omeprazole Low Dose |
Primary outcome
Mortality
Time frame: 1 month
4 secondary outcomes
Rebleeding
Time frame: one month
Surgery
Time frame: one month
Length of hospital stay
Time frame: one month
Blood transfusions
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Gastroduodenal Ulcer
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
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.
Marouf Alhalabi, MD principal investigator
Damascus Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole High dose and Omeprazole Low dose in people with 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 5 inclusion and 2 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: withdrawn, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mortality (time frame: 1 month). 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.