Post-ERCP Acute PancreatitisPhase 1NCT04049734
Oral Losartan in Prevention of Post-ERCP Paancreatitis
A Phase 1 study testing oral losatan in people with Post-ERCP Acute Pancreatitis, run by Ain Shams University.
Trial summary
Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- oral losatan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2017
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient indicated for ERCP
- Patients with obstructive jaundice.
- Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.
Who cannot join
- Patients refusing to undergo the procedure or signing the informed consent
- Patients with clinically evident acute pancreatitis before the procedure
- Patients with previous endoscopic or surgical sphincterotomy
- Patients with current use of losartan
- Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
- Patients receiving NSAIDS within a week prior to assessment
- Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.
About this study
Official title: Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis
Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- oral losatan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral losatanDrug
50 mg of oral losartan one hour before the ERCP once
| Study group | Role | What they receive |
|---|---|---|
| patients received the oral losartan | Active comparator | 50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis Receives: Drug: oral losatan |
| patients didn't receive the oral losartan | No intervention | 50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with development of acute pancreatitis
Number of participants with development of abdominal pain and elevated serum amylase and/or lipase
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study startJan 2015
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Abou Bakr Saleh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049734
- Sponsor's protocol ID
- 689
- Status last verified
- Aug 2019
- First submitted
- 3 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT04049734
- Acronym / sponsor ID
- 689
- Conditions
- Post-ERCP Acute Pancreatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Aug 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.
Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients received the oral losartan | Active comparator | Drug: oral losatan50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis |
| patients didn't receive the oral losartan | No intervention | –50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any adult patient indicated for ERCP
- Patients with obstructive jaundice.
- Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.
Key exclusion criteria (7 listed)
- Patients refusing to undergo the procedure or signing the informed consent
- Patients with clinically evident acute pancreatitis before the procedure
- Patients with previous endoscopic or surgical sphincterotomy
- Patients with current use of losartan
- Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
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 |
|---|---|---|
| oral losatan50 mg of oral losartan one hour before the ERCP once | Drug | patients received the oral losartan |
Primary outcome
Number of participants with development of acute pancreatitis
Time frame: 24 hours
Number of participants with development of abdominal pain and elevated serum amylase and/or lipase
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 9 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral losatan in people with Post-ERCP Acute Pancreatitis, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 9 Aug 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Number of participants with development of acute pancreatitis (time frame: 24 hours). 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 9 Aug 2019.