Acute PancreatitisPhase 2/3NCT04743570
Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis
A Phase 2/3 study testing Methylnaltrexone treatment in people with Acute Pancreatitis, run by Asbjørn Mohr Drewes at 4 sites in Denmark.
Trial summary
This study will investigate the effect of peripheral acting opioid antagonist (PAMORA) on the disease course of patients with acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating hospitalized patients with acute pancreatitis with a PAMORA (methylnaltrexone). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Methylnaltrexone treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 4 sitesDenmark
- Study dates
- 14 May 2021to 20 Apr 2023
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent before any study specific procedures
- Able to read and understand Danish
- Male or female age between 18 and 80 years
- The researcher believes that the participant understands what the study entails, is capable of following instructions, can attend when needed, and is expected to complete the study
- The investigator will ensure that fertile female participants have a negative pregnancy test before treatment initiation and use contraception during the study period. The following methods of contraception, if properly used, are generally considered reliable: oral contraceptives, patch contraceptives, injection contraceptives, vaginal contraceptive ring, intrauterine device, surgical sterilization (bilateral tubal ligation), vasectomized partner, double barrier (condom and pessary), or sexual abstinence. Methods of contraception will be documented in the source documents
- At least two of the following criteria need to be fulfilled to establish a diagnosis of AP (according to the revised Atlanta criteria (16)): i) abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back); ii) serum amylase activity at least three times greater than the upper limit of normal; and iii) characteristic findings of AP on diagnostic imaging
- Predicted moderate or severe AP based on 2 or more systemic inflammatory response syndrome criteria upon admission
Who cannot join
- Definitive chronic pancreatitis according to the M-ANNHEIM criteria
- Known allergy towards study medication
- Known or suspected major stenosis or perforation of the intestines
- Known or suspected abdominal cancer (incl. intestine, pancreas and the biliary tree)
- Pre-existing renal insufficiency (defined as habitual estimated glomerular filtration rate below 45)
- Severe pre-existing comorbidities (assessed by investigator upon inclusion)
Show all 9Show fewer
- Severe non-pancreaticobiliary infections or sepsis caused by non-pancreaticobiliary disease
- Child-Pugh class B or C liver cirrhosis
- Females that are currently lactating
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Aalborg, Jutland, 9000
Digestive Disease Center K, Bispebjerg University Hospital
Bispebjerg
Gastrounit, Hvidovre University Hospital
Hvidovre
Odense Pancreas Center
Svendborg
About this study
Official title: Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis - An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial
This study will investigate the effect of peripheral acting opioid antagonist (PAMORA) on the disease course of patients with acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating hospitalized patients with acute pancreatitis with a PAMORA (methylnaltrexone).
Read the detailed description
In this study, the effects of peripheral acting µ-opioid receptor antagonists (PAMORA) on disease development and progression in patients with acute pancreatitis (AP) will be investigated. Patients with AP will be administered Methylnaltrexone (Relistor®) intravenously. This medication is defined as the investigational product. Relistor® is approved and sold on the Danish marked for treatment of opioid-induced constipation. This PAMORA have not previously been investigated in patients with pancreatitis. The dose regimes for this study will be according to label. It has previously been shown, in patients with opioid-induced obstipation and healthy subjects, that opioid antagonism incl. PAMORA treatment increases gut motility, relaxes gastrointestinal sphincters, increases the intestinal water content and improves the immune response, without affecting analgesia. The affinity of PAMORAs to the µ-opioid receptors is much stronger than opioid analgesics. Therefore, they as antagonists have the potential to counteract the harmful effects of opioids on the gut mucosa, bacterial translocation and inflammation despite the high levels of exogenous opioids present in patients with pancreatitis. PAMORAs do not cross the blood-brain barrier and consequently do not interfere with analgesia or other central effects of opioids.
We hypothesize that treatment with the PAMORA methylnaltrexone will antagonize the harmful effects of opioids without reducing analgesia in patients with AP and hence reduce disease severity and improve clinical outcomes. If successful, this sub-study will for the first time document the effects of a targeted pharmacotherapy in AP with the potential benefit of improved patient outcomes.
- Conditions
- Acute Pancreatitis
- Being tested
- Placebo treatment, Methylnaltrexone treatment
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo treatmentDrug
Active drug/placebo is given for the first 5 days of admission.
Methylnaltrexone treatmentDrug
Active drug/placebo is given for the first 5 days of admission.
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment | Placebo comparator | Placebo consisting of Ringer's lactate in matched volume to active drug is added to 1000 mL Ringer's lactate solution and given as a continues infusion over 24 hours using an infusion pump. Receives: Drug: Placebo treatment |
| Methylnaltrexone treatment | Active comparator | 0.15 mg/kg methylnaltrexone will be dissolved in 1000 mL Ringer's lactate solution and given as a continues infusion over 24 hours using an infusion pump. Receives: Drug: Methylnaltrexone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatitis activity scoring system
Difference in Pancreatitis activity scoring system (PASS) score between the methylnaltrexone group and the placebo group. The PASS-score is a weighted score of presence of organ failure, number of criterias of Systemic Inflammatory Response Syndrome fulfilled, abdominal pain (0-10), morphine equivalent dose (mg) and tolerance to solid food. Minimum value is 0 and higher score is equal to higher disease activity.
Documentation for the PASS can be found on the following link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5519418/
Measured: 48 hours after randomization
Secondary outcomes (16)
Pancreatitis activity scoring system
Difference PASS scores between subgroups
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Difference in assessments of circulating proinflammatory marker
C-Reactive Protein (mg/L)
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Difference in assessments of circulating pro- and anti-inflammatory markers
Interleukin-6, Interleukin-8, Interleukin-18, Tumor necrosis factor alpha, Cluster of Differentiation 163 (serum) (all measured in pg/mL)
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Intestinal permeability
Difference in intestinal permeability between subgroups using the oral polyethylene glycol 400/4000 test
Measured: From 48 to 72 hours after randomization
Intestinal motility
Difference in intestinal motility assessed by means of gut/colon transit using a CT-based radiopaque marker method between subgroups
Measured: 5 (+/- 1 day) after randomization
Pancreatic complications
Difference in pancreatic complications (e.g. edema, fluid collections and necrosis) assessed and quantified with contrast-enhanced CT
Measured: Day 5 (+/- 1 day) after randomization
Pain intensity
Difference between subgroups in pain intensity measured with the questionaire "modified Brief Pain Inventory short form" on visual analogue scale from 0-10 (0 is no pain and 10 is worst pain).
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Gut function (BSFS)
Difference between subgroups in gut function assessed by The Bristol Stool Form Scale for assessment of stool frequency as well as stool consistency (scale from 1-7, where 1 is firmeste and 7 is softest)
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Gut function (GSRS)
Difference between subgroups in gut function assessed by Gastrointestinal Symptom Rating Scale which is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Quantification of analgesics
Difference between subgroups in given dose of analgesics (separated into opioids and non-opioids) based on name, administration route and dose
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Use of nutritional support
Difference between subgroups in the use of nutritional support with registration of the used of either oral nutrition, enteral or parenteral nutrition.
Measured: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Days of hospitalization
Difference between subgroups in days of hospitalization and days on intensive ward
Measured: Observation period starts from day of randomization and ends after 12 months or on the day of discharge which ever comes first
Use of invasive treatment
Difference between subgroups in use of invasive treatment (e.g. use of drain or surgery) measured in type and frequency of use
Measured: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Mortality
Difference between subgroups in mortality rate
Measured: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Health resource utilization
Difference in health resource utilization (measured in frequency and type of health services used (e.g. blood sample, MRI etc.) that can be converted into danish currency for economic analyses) between subgroups based on service codes (all services have unique service codes stored digitally).
Measured: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Disease severity
Disease severity classified by the revised Atlanta classification system in 3 levels; Mild, Moderate or Severe acute pancreatitis. (Mild acute pancreatitis, with no organ failure, local or systemic complications, Moderately severe acute pancreatitis is with presence of transient organ failure, local complications or exacerbation of co-morbid disease. Severe acute pancreatitis with persistent organ failure (>48 h).
Measured: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start14 May 2021
- Primary completion9 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asbjørn Mohr Drewes
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Hvidovre University Hospital, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Sponsor-investigator, Asbjørn Mohr Drewes, Aalborg University Hospital
- Investigators
- Asbjørn M. Drewes, Professor, Study chair, Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743570
- Sponsor's protocol ID
- PAMORA_AP, PAMORA-1
- Other IDs
- 2020-002313-18, N-20200060
- Status last verified
- Apr 2023
- First submitted
- 28 Jan 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Knoph CS, Cook ME, Novovic S, Hansen MB, Mortensen MB, Nielsen LBJ, Hogsberg IM, Salomon C, Neergaard CEL, Aajwad AJ, Pandanaboyana S, Sorensen LS, Thorlacius-Ussing O, Frokjaer JB, Olesen SS, Drewes AM. No Effect of Methylnaltrexone on Acute Pancreatitis Severity: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2307-2316. doi: 10.14309/ajg.0000000000002904. Epub 2024 Jun 25.
PubMed 38916223Knoph CS, Cook ME, Fjelsted CA, Novovic S, Mortensen MB, Nielsen LBJ, Hansen MB, Frokjaer JB, Olesen SS, Drewes AM. Effects of the peripherally acting mu-opioid receptor antagonist methylnaltrexone on acute pancreatitis severity: study protocol for a multicentre double-blind randomised placebo-controlled interventional trial, the PAMORA-AP trial. Trials. 2021 Dec 19;22(1):940. doi: 10.1186/s13063-021-05885-3.
PubMed 34924020
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis - An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04743570
- Acronym / sponsor ID
- PAMORA_AP, PAMORA-1
- Conditions
- Acute Pancreatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Asbjørn Mohr DrewesUniversity, hospital or other
- Collaborators
- Odense University Hospital, Hvidovre University Hospital, University Hospital Bispebjerg and Frederiksberg
- Study start
- 14 May 2021 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 8 Feb 2021 (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.
This study will investigate the effect of peripheral acting opioid antagonist (PAMORA) on the disease course of patients with acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating hospitalized patients with acute pancreatitis with a PAMORA (methylnaltrexone).
Detailed description
In this study, the effects of peripheral acting µ-opioid receptor antagonists (PAMORA) on disease development and progression in patients with acute pancreatitis (AP) will be investigated. Patients with AP will be administered Methylnaltrexone (Relistor®) intravenously. This medication is defined as the investigational product. Relistor® is approved and sold on the Danish marked for treatment of opioid-induced constipation. This PAMORA have not previously been investigated in patients with pancreatitis. The dose regimes for this study will be according to label. It has previously been shown, in patients with opioid-induced obstipation and healthy subjects, that opioid antagonism incl. PAMORA treatment increases gut motility, relaxes gastrointestinal sphincters, increases the intestinal water content and improves the immune response, without affecting analgesia. The affinity of PAMORAs to the µ-opioid receptors is much stronger than opioid analgesics. Therefore, they as antagonists have the potential to counteract the harmful effects of opioids on the gut mucosa, bacterial translocation and inflammation despite the high levels of exogenous opioids present in patients with pancreatitis. PAMORAs do not cross the blood-brain barrier and consequently do not interfere with analgesia or other central effects of opioids.
We hypothesize that treatment with the PAMORA methylnaltrexone will antagonize the harmful effects of opioids without reducing analgesia in patients with AP and hence reduce disease severity and improve clinical outcomes. If successful, this sub-study will for the first time document the effects of a targeted pharmacotherapy in AP with the potential benefit of improved patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment | Placebo comparator | Drug: Placebo treatmentPlacebo consisting of Ringer's lactate in matched volume to active drug is added to 1000 mL Ringer's lactate solution and given as a continues infusion over 24 hours using an infusion pump. |
| Methylnaltrexone treatment | Active comparator | Drug: Methylnaltrexone treatment0.15 mg/kg methylnaltrexone will be dissolved in 1000 mL Ringer's lactate solution and given as a continues infusion over 24 hours using an infusion pump. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent before any study specific procedures
- Able to read and understand Danish
- Male or female age between 18 and 80 years
- The researcher believes that the participant understands what the study entails, is capable of following instructions, can attend when needed, and is expected to complete the study
- The investigator will ensure that fertile female participants have a negative pregnancy test before treatment initiation and use contraception during the study period. The following methods of contraception, if properly used, are generally considered reliable: oral contraceptives, patch contraceptives, injection contraceptives, vaginal contraceptive ring, intrauterine device, surgical sterilization (bilateral tubal ligation), vasectomized partner, double barrier (condom and pessary), or sexual abstinence. Methods of contraception will be documented in the source documents
Key exclusion criteria (9 listed)
- Definitive chronic pancreatitis according to the M-ANNHEIM criteria
- Known allergy towards study medication
- Known or suspected major stenosis or perforation of the intestines
- Known or suspected abdominal cancer (incl. intestine, pancreas and the biliary tree)
- Pre-existing renal insufficiency (defined as habitual estimated glomerular filtration rate below 45)
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 |
|---|---|---|
| Placebo treatmentActive drug/placebo is given for the first 5 days of admission. | Drug | Placebo treatment |
| Methylnaltrexone treatmentActive drug/placebo is given for the first 5 days of admission. | Drug | Methylnaltrexone treatment |
Primary outcome
Pancreatitis activity scoring system
Time frame: 48 hours after randomization
Difference in Pancreatitis activity scoring system (PASS) score between the methylnaltrexone group and the placebo group. The PASS-score is a weighted score of presence of organ failure, number of criterias of Systemic Inflammatory Response Syndrome fulfilled, abdominal pain (0-10), morphine equivalent dose (mg) and tolerance to solid food. Minimum value is 0 and higher score is equal to higher disease activity. Documentation for the PASS can be found on the following link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5519418/
16 secondary outcomes
Pancreatitis activity scoring system
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Difference in assessments of circulating proinflammatory marker
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Difference in assessments of circulating pro- and anti-inflammatory markers
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Intestinal permeability
Time frame: From 48 to 72 hours after randomization
Intestinal motility
Time frame: 5 (+/- 1 day) after randomization
Pancreatic complications
Time frame: Day 5 (+/- 1 day) after randomization
Pain intensity
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Gut function (BSFS)
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Gut function (GSRS)
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Quantification of analgesics
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Use of nutritional support
Time frame: 24 hours after randomization and every 24 hours untill end of study at day 5 (after 120 hours) and again at the day 14 follow-up visit
Days of hospitalization
Time frame: Observation period starts from day of randomization and ends after 12 months or on the day of discharge which ever comes first
Use of invasive treatment
Time frame: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Mortality
Time frame: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Health resource utilization
Time frame: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
Disease severity
Time frame: Observation period starts from day of randomization and ends after 12 months or on the day of discharge whichever comes first
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 21 Apr 2023.
- Derived from this study: PubMed 38916223Knoph CS, Cook ME, Novovic S, Hansen MB, Mortensen MB, Nielsen LBJ, Hogsberg IM, Salomon C, Neergaard CEL, Aajwad AJ, Pandanaboyana S, Sorensen LS, Thorlacius-Ussing O, Frokjaer JB, Olesen SS, Drewes AM. No Effect of Methylnaltrexone on Acute Pancreatitis Severity: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2307-2316. doi: 10.14309/ajg.0000000000002904. Epub 2024 Jun 25.
- Derived from this study: PubMed 34924020Knoph CS, Cook ME, Fjelsted CA, Novovic S, Mortensen MB, Nielsen LBJ, Hansen MB, Frokjaer JB, Olesen SS, Drewes AM. Effects of the peripherally acting mu-opioid receptor antagonist methylnaltrexone on acute pancreatitis severity: study protocol for a multicentre double-blind randomised placebo-controlled interventional trial, the PAMORA-AP trial. Trials. 2021 Dec 19;22(1):940. doi: 10.1186/s13063-021-05885-3.
- Individual participant dataSharing planned: Yes
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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.
Asbjørn M. Drewes, Professor study chair
Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylnaltrexone treatment in people with Acute Pancreatitis, run by Asbjørn Mohr Drewes at 4 sites in Denmark.
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 7 inclusion and 9 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pancreatitis activity scoring system (time frame: 48 hours after randomization). 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 NCT04743570, which also lists 2 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 21 Apr 2023.