Bleeding Peptic UlcerEarly Phase 1NCT04170270
Oral Omeprazole in Bleeding Peptic Ulcer
A Early Phase 1 study testing Omeprazole in people with Bleeding Peptic Ulcer, run by Assiut University.
Trial summary
Find out if there is a significant difference between clinical outcome among the patients with bleeding peptic ulcer treated with oral omeprazole compared to those treated with intravenous omeprazole. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bleeding Peptic Ulcer
- What is being tested?
- Omeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Jan 2021
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Peptic ulcer of the esophagus (lower part), stomach, and duodenum with one or more endoscopic signs of high risk for re-bleeding (ulcer bed exhibiting active bleeding (spurting/oozing), non-bleeding visible vessel, and adherent clot).
Who cannot join
- Pregnant patients.
- Pediatric patients (less than 18 years).
- Ulcer with endoscopic signs suspicious of neoplastic disease (greater than 3 cm, irregular shape, uneven base, irregular edges, moth eaten appearance of peri ulcer folds, associated with a mass)
- Use of PPI 14 days or less before enrollment.
- Other sources of UGIB.
- Bleeding tendency (platelet count <50,000/mL, prothrombin time > 14 sec, prothrombin concentration <30%, anticoagulant therapy)
- Uremia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oral Versus Intravenous Omeprazole in Management of Bleeding Peptic Ulcer: Randomized Controlled Trial
Find out if there is a significant difference between clinical outcome among the patients with bleeding peptic ulcer treated with oral omeprazole compared to those treated with intravenous omeprazole.
Read the detailed description
Globally, Peptic ulcer disease is the most common cause of upper gastrointestinal bleeding (UGIB), accounting for about 50% of cases. It remains a serious medical problem with significant morbidity and mortality (1, 2). However, in Egypt, bleeding peptic ulcer comes second to the bleeding varices in order of frequency (approximately 30%) (3).
Over the past 20 years, mortality resulting from bleeding peptic ulcer significantly decreased through researches on primary endoscopic hemostasis, due to improvement in pre- and post-endoscopic management, as well as identification of patients at a risk of catastrophic events-for close observation and focused intensive management (4).However, the risk of patients with bleeding peptic ulcers significantly increased owing to the aging population with multiple comorbidities, as well as the increasing use of aspirin and non-steroidal anti-inflammatory drugs (5).
Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcer and is now recommended as the first hemostatic modality for these patients. However, there is a high risk of peptic ulcer re-bleeding in 14-36% of patients, in spite of efficient endoscopic intervention (6).
Intravenous proton pump inhibitors (PPIs) are effective as adjuvant pharmacotherapy in preventing re-bleeding in these patients (7).
Gastric acid inhibits clot formation and promotes clot lyses and accordingly, disturbs hemostasis of ulcers in the stomach and duodenum (8). Therefore, reduction of gastric acid secretion can prevent ulcer re-bleeding.
The use of high-dose intravenous PPIs is standard practice in the management of upper gastrointestinal bleeding (9).
High dose IV PPI has faster adequate acid suppression effect (gastric acid PH > 6) than high dose oral PPI . In addition, Compared to standard dose of oral PPI, high dose oral PPI has faster acid suppression (10, 11). However, the optimal route, dose, and duration of PPI therapy after endoscopic therapy of a bleeding peptic ulcer remain controversial.
UGIB continues to represent a significant clinical and economic burden to society. Intravenous PPI therapy is more expensive than oral one. Therefore, the therapy has to be assessed from a cost-effectiveness perspective (12).
Several controlled trials and meta-analyses have shown the comparable efficacy of IV and oral PPI in treating ulcers at high risk of re-bleeding after endoscopic therapy. However, further studies to confirm their results were recommended (13, 14).
The investigators will evaluate and compare the efficacy and safety profile of oral PPI compared to IV PPI in preventing re-bleeding from peptic ulcers.
- Conditions
- Bleeding Peptic Ulcer
- Being tested
- Omeprazole
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Pre endoscopically: all patients will receive 80 mg omeprazole by 30 minute IV infusion.
After performing upper endoscopy (with initial hemostasis), the patient will be randomly allocated into two groups; group A patients will receive oral omeprazole, while group B patients are intended to receive IV omeprazole.
For patients of group A, omeprazole 40 mg will be administrated orally every 12 hours for 72 hours. Regarding group B, continuous infusion of omeprazole will be administrated at a rate of 8 mg/hour, for 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| oral omeprazole | Experimental | oral omeprazole in bleeding peptic ulcer after endoscopic therapy 40 mg twice daily for 72 hours Receives: Drug: Omeprazole |
| intravenous omeprazole | Active comparator | intravenous omeprazole in bleeding peptic ulcer after endoscopic therapy as continuous infusion at rate of 8 mg/hour for 72 hours Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent bleeding
Re-bleeding will be suspected if hematemesis or melena recur or of the patient develop one or more of the following: orthostatic hypotension, unstable vital signs (systolic blood pressure< 90 mmHg and pulse rate> 120/min), reduction of hemoglobin level> 2 gm/dL (despite blood transfusion), during 24 hour period.
Measured: 15 days
Secondary outcomes (1)
-Length of hospital stay. -Admission to ICU. - Blood transfusion (number of units of packes RBCs) -Angioembolization. -Surgery for uncontrolled recurrent bleeding.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bleeding Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between oral and intravenous omeprazole in management of bleeding peptic ulcer
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Nasr El Din Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170270
- Sponsor's protocol ID
- bleeding peptic ulcer
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silverstein FE, Gilbert DA, Tedesco FJ, Buenger NK, Persing J. The national ASGE survey on upper gastrointestinal bleeding. I. Study design and baseline data. Gastrointest Endosc. 1981 May;27(2):73-9. doi: 10.1016/s0016-5107(81)73155-9. No abstract available.
PubMed 6971775Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.
PubMed 7627034Elwakil R, Reda MA, Abdelhakam SM, Ghoraba DM, Ibrahim WA. Causes and outcome of upper gastrointestinal bleeding in Emergency Endoscopy Unit of Ain Shams University Hospital. J Egypt Soc Parasitol. 2011 Aug;41(2):455-67.
PubMed 21980783Quan S, Frolkis A, Milne K, Molodecky N, Yang H, Dixon E, Ball CG, Myers RP, Ghosh S, Hilsden R, van Zanten SV, Kaplan GG. Upper-gastrointestinal bleeding secondary to peptic ulcer disease: incidence and outcomes. World J Gastroenterol. 2014 Dec 14;20(46):17568-77. doi: 10.3748/wjg.v20.i46.17568.
PubMed 25516672Melcarne L, Garcia-Iglesias P, Calvet X. Management of NSAID-associated peptic ulcer disease. Expert Rev Gastroenterol Hepatol. 2016 Jun;10(6):723-33. doi: 10.1586/17474124.2016.1142872. Epub 2016 Mar 2.
PubMed 26775657Hwang JH, Fisher DA, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, Early DS, Evans JA, Fanelli RD, Foley K, Fukami N, Jain R, Jue TL, Khan KM, Lightdale J, Malpas PM, Maple JT, Pasha S, Saltzman J, Sharaf R, Shergill AK, Dominitz JA, Cash BD; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. The role of endoscopy in the management of acute non-variceal upper GI bleeding. Gastrointest Endosc. 2012 Jun;75(6):1132-8. doi: 10.1016/j.gie.2012.02.033. No abstract available.
PubMed 22624808Marmo R, Rotondano G, Piscopo R, Bianco MA, D'Angella R, Cipolletta L. Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials. Am J Gastroenterol. 2007 Feb;102(2):279-89; quiz 469. doi: 10.1111/j.1572-0241.2006.01023.x.
PubMed 17311650Cheng HC, Sheu BS. Intravenous proton pump inhibitors for peptic ulcer bleeding: Clinical benefits and limits. World J Gastrointest Endosc. 2011 Mar 16;3(3):49-56. doi: 10.4253/wjge.v3.i3.49.
PubMed 21455342Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.
PubMed 19221370Sachs G, Shin JM, Howden CW. Review article: the clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006 Jun;23 Suppl 2:2-8. doi: 10.1111/j.1365-2036.2006.02943.x.
PubMed 16700898Laine L, Shah A, Bemanian S. Intragastric pH with oral vs intravenous bolus plus infusion proton-pump inhibitor therapy in patients with bleeding ulcers. Gastroenterology. 2008 Jun;134(7):1836-41. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.
PubMed 18423628Barkun AN, Herba K, Adam V, Kennedy W, Fallone CA, Bardou M. The cost-effectiveness of high-dose oral proton pump inhibition after endoscopy in the acute treatment of peptic ulcer bleeding. Aliment Pharmacol Ther. 2004 Jul 15;20(2):195-202. doi: 10.1111/j.1365-2036.2004.02035.x.
PubMed 15233700Sung JJ, Suen BY, Wu JC, Lau JY, Ching JY, Lee VW, Chiu PW, Tsoi KK, Chan FK. Effects of intravenous and oral esomeprazole in the prevention of recurrent bleeding from peptic ulcers after endoscopic therapy. Am J Gastroenterol. 2014 Jul;109(7):1005-10. doi: 10.1038/ajg.2014.105. Epub 2014 Apr 29.
PubMed 24777150
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Omeprazole in Management of Bleeding Peptic Ulcer: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04170270
- Acronym / sponsor ID
- bleeding peptic ulcer
- Conditions
- Bleeding Peptic Ulcer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 20 Nov 2019 (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.
Find out if there is a significant difference between clinical outcome among the patients with bleeding peptic ulcer treated with oral omeprazole compared to those treated with intravenous omeprazole.
Detailed description
Globally, Peptic ulcer disease is the most common cause of upper gastrointestinal bleeding (UGIB), accounting for about 50% of cases. It remains a serious medical problem with significant morbidity and mortality (1, 2). However, in Egypt, bleeding peptic ulcer comes second to the bleeding varices in order of frequency (approximately 30%) (3).
Over the past 20 years, mortality resulting from bleeding peptic ulcer significantly decreased through researches on primary endoscopic hemostasis, due to improvement in pre- and post-endoscopic management, as well as identification of patients at a risk of catastrophic events-for close observation and focused intensive management (4).However, the risk of patients with bleeding peptic ulcers significantly increased owing to the aging population with multiple comorbidities, as well as the increasing use of aspirin and non-steroidal anti-inflammatory drugs (5).
Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcer and is now recommended as the first hemostatic modality for these patients. However, there is a high risk of peptic ulcer re-bleeding in 14-36% of patients, in spite of efficient endoscopic intervention (6).
Intravenous proton pump inhibitors (PPIs) are effective as adjuvant pharmacotherapy in preventing re-bleeding in these patients (7).
Gastric acid inhibits clot formation and promotes clot lyses and accordingly, disturbs hemostasis of ulcers in the stomach and duodenum (8). Therefore, reduction of gastric acid secretion can prevent ulcer re-bleeding.
The use of high-dose intravenous PPIs is standard practice in the management of upper gastrointestinal bleeding (9).
High dose IV PPI has faster adequate acid suppression effect (gastric acid PH > 6) than high dose oral PPI . In addition, Compared to standard dose of oral PPI, high dose oral PPI has faster acid suppression (10, 11). However, the optimal route, dose, and duration of PPI therapy after endoscopic therapy of a bleeding peptic ulcer remain controversial.
UGIB continues to represent a significant clinical and economic burden to society. Intravenous PPI therapy is more expensive than oral one. Therefore, the therapy has to be assessed from a cost-effectiveness perspective (12).
Several controlled trials and meta-analyses have shown the comparable efficacy of IV and oral PPI in treating ulcers at high risk of re-bleeding after endoscopic therapy. However, further studies to confirm their results were recommended (13, 14).
The investigators will evaluate and compare the efficacy and safety profile of oral PPI compared to IV PPI in preventing re-bleeding from peptic ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- comparison between oral and intravenous omeprazole in management of bleeding peptic ulcer
| Arm | Type | Receives |
|---|---|---|
| oral omeprazole | Experimental | Drug: Omeprazoleoral omeprazole in bleeding peptic ulcer after endoscopic therapy 40 mg twice daily for 72 hours |
| intravenous omeprazole | Active comparator | Drug: Omeprazoleintravenous omeprazole in bleeding peptic ulcer after endoscopic therapy as continuous infusion at rate of 8 mg/hour for 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peptic ulcer of the esophagus (lower part), stomach, and duodenum with one or more endoscopic signs of high risk for re-bleeding (ulcer bed exhibiting active bleeding (spurting/oozing), non-bleeding visible vessel, and adherent clot).
Key exclusion criteria (7 listed)
- Pregnant patients.
- Pediatric patients (less than 18 years).
- Ulcer with endoscopic signs suspicious of neoplastic disease (greater than 3 cm, irregular shape, uneven base, irregular edges, moth eaten appearance of peri ulcer folds, associated with a mass)
- Use of PPI 14 days or less before enrollment.
- Other sources of UGIB.
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 |
|---|---|---|
| OmeprazolePre endoscopically: all patients will receive 80 mg omeprazole by 30 minute IV infusion. After performing upper endoscopy (with initial hemostasis), the patient will be randomly allocated into two groups; group A patients will receive oral omeprazole, while group B patients are intended to receive IV omeprazole. For patients of group A, omeprazole 40 mg will be administrated orally every 12 hours for 72 hours. Regarding group B, continuous infusion of omeprazole will be administrated at a rate of 8 mg/hour, for 72 hours. | Drug | intravenous omeprazole, oral omeprazole |
Primary outcome
recurrent bleeding
Time frame: 15 days
Re-bleeding will be suspected if hematemesis or melena recur or of the patient develop one or more of the following: orthostatic hypotension, unstable vital signs (systolic blood pressure< 90 mmHg and pulse rate> 120/min), reduction of hemoglobin level> 2 gm/dL (despite blood transfusion), during 24 hour period.
1 secondary outcome
-Length of hospital stay. -Admission to ICU. - Blood transfusion (number of units of packes RBCs) -Angioembolization. -Surgery for uncontrolled recurrent bleeding.
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Background: PubMed 6971775Silverstein FE, Gilbert DA, Tedesco FJ, Buenger NK, Persing J. The national ASGE survey on upper gastrointestinal bleeding. I. Study design and baseline data. Gastrointest Endosc. 1981 May;27(2):73-9. doi: 10.1016/s0016-5107(81)73155-9. No abstract available.
- Background: PubMed 7627034Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.
- Background: PubMed 21980783Elwakil R, Reda MA, Abdelhakam SM, Ghoraba DM, Ibrahim WA. Causes and outcome of upper gastrointestinal bleeding in Emergency Endoscopy Unit of Ain Shams University Hospital. J Egypt Soc Parasitol. 2011 Aug;41(2):455-67.
- Background: PubMed 25516672Quan S, Frolkis A, Milne K, Molodecky N, Yang H, Dixon E, Ball CG, Myers RP, Ghosh S, Hilsden R, van Zanten SV, Kaplan GG. Upper-gastrointestinal bleeding secondary to peptic ulcer disease: incidence and outcomes. World J Gastroenterol. 2014 Dec 14;20(46):17568-77. doi: 10.3748/wjg.v20.i46.17568.
- Background: PubMed 26775657Melcarne L, Garcia-Iglesias P, Calvet X. Management of NSAID-associated peptic ulcer disease. Expert Rev Gastroenterol Hepatol. 2016 Jun;10(6):723-33. doi: 10.1586/17474124.2016.1142872. Epub 2016 Mar 2.
- Background: PubMed 22624808Hwang JH, Fisher DA, Ben-Menachem T, Chandrasekhara V, Chathadi K, Decker GA, Early DS, Evans JA, Fanelli RD, Foley K, Fukami N, Jain R, Jue TL, Khan KM, Lightdale J, Malpas PM, Maple JT, Pasha S, Saltzman J, Sharaf R, Shergill AK, Dominitz JA, Cash BD; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. The role of endoscopy in the management of acute non-variceal upper GI bleeding. Gastrointest Endosc. 2012 Jun;75(6):1132-8. doi: 10.1016/j.gie.2012.02.033. No abstract available.
- Background: PubMed 17311650Marmo R, Rotondano G, Piscopo R, Bianco MA, D'Angella R, Cipolletta L. Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials. Am J Gastroenterol. 2007 Feb;102(2):279-89; quiz 469. doi: 10.1111/j.1572-0241.2006.01023.x.
- Background: PubMed 21455342Cheng HC, Sheu BS. Intravenous proton pump inhibitors for peptic ulcer bleeding: Clinical benefits and limits. World J Gastrointest Endosc. 2011 Mar 16;3(3):49-56. doi: 10.4253/wjge.v3.i3.49.
- Background: PubMed 19221370Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.
- Background: PubMed 16700898Sachs G, Shin JM, Howden CW. Review article: the clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006 Jun;23 Suppl 2:2-8. doi: 10.1111/j.1365-2036.2006.02943.x.
- Background: PubMed 18423628Laine L, Shah A, Bemanian S. Intragastric pH with oral vs intravenous bolus plus infusion proton-pump inhibitor therapy in patients with bleeding ulcers. Gastroenterology. 2008 Jun;134(7):1836-41. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.
- Background: PubMed 15233700Barkun AN, Herba K, Adam V, Kennedy W, Fallone CA, Bardou M. The cost-effectiveness of high-dose oral proton pump inhibition after endoscopy in the acute treatment of peptic ulcer bleeding. Aliment Pharmacol Ther. 2004 Jul 15;20(2):195-202. doi: 10.1111/j.1365-2036.2004.02035.x.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omeprazole in people with Bleeding Peptic Ulcer, run by Assiut University.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeinab Nasr El Din Ahmed, resident doctor (+201021659698, zeinabnasr9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent bleeding (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04170270, which also lists 13 linked publications.
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 25 Nov 2019.