Pancreatitis, AcutePhase 2/3NCT04966559
Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis
A Phase 2/3 study testing Naldemedine 0.2 MG Oral Tablet in people with Pancreatitis, Acute, run by Asbjørn Mohr Drewes at 5 sites in 2 countries.
Trial summary
This study will investigate the effect of a peripheral acting opioid antagonist (PAMORA) on the disease course of patients with recurrent acute inflammation of the pancreas (acute pancreatitis). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- Naldemedine 0.2 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Jan 2022to 1 Jun 2024
- 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 74 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 or Swedish (depending on site)
- Male or female age between 18 and 74 years
- At least one attack of non-biliary AP (as defined by the revised Atlanta criteria) within the last 12 months and at least two attacks within 5 years
- Clinically stable at time of inclusion
- 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
Who cannot join
- 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 eGFR below 45)
- Female participants that are lactating
- Severe pre-existing comorbidities (assessed by investigator upon inclusion)
Show all 9Show fewer
- Attack of AP requiring admission within two weeks prior to inclusion
- Gallstone etiology of RAP (MRCP or endoscopic ultrasound excluding biliary etiology of AP must be available prior to enrolment as part of the protocol)
- Treatment with potent CYP3A4-inhibitors (ketoconazol, itraconzol, ritonavir) or P-gp inhibitors (e.g. cyclosporine).
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
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
Sweden1 site
Karolinska University Hospital
Stockholm, Solna (l1:00), SE-171 76
About this study
Official title: Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial
This study will investigate the effect of a peripheral acting opioid antagonist (PAMORA) on the disease course of patients with recurrent acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating outpatients suffering from recurrent acute pancreatitis with a PAMORA (naldemedine) for 12 months.
Read the detailed description
In this study, the effects of a peripheral acting µ-opioid receptor antagonist (PAMORA) on disease recurrence and progression in patients with recurrent acute pancreatitis (RAP) will be investigated. Patients with RAP will be administered 0,2 mg naldemedine orally daily or matching placebo. This medication is defined as the investigational product. Naldemedine is approved by the European Medical Agency 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.
It is hypothesized that treatment with the PAMORA naldemedine will antagonize the harmful effects of opioids without reducing analgesia in patients with RAP and hence reduce disease severity and improve clinical outcomes. If successful, this study will for the first time document the effects of a targeted pharmacotherapy in RAP with the potential benefit of improved patient outcomes.
- Conditions
- Pancreatitis, Acute
- Being tested
- Placebo treatment, Naldemedine 0.2 MG Oral Tablet
- 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 handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days.
Naldemedine 0.2 MG Oral TabletDrug
Active drug/placebo is handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment | Placebo comparator | Film-coated matched placebo-tablets consisting of:
Core:
Mannitol, USP/Ph. Eur./JP Croscarmellose Sodium, NF/Ph. Eur./JP Magnesium Stearate, NF/Ph. Eur./JP
Coating:
Opadry Yellow Purified Water, USP/EP Receives: Drug: Placebo treatment |
| Naldemedine treatment | Active comparator | Film-coated matched active-tablets consisting of:
Core:
Naldemedine Tosylate (0,2 mg) Mannitol, USP/Ph. Eur./JP Croscarmellose Sodium, NF/Ph. Eur./JP Magnesium Stearate, NF/Ph. Eur./JP
Coating:
Opadry Yellow Purified Water, USP/EP Receives: Drug: Naldemedine 0.2 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AP attacks verified by the Atlanta Criteria
The primary outcome is defined as time to (recurrent) AP attack(s) verified by the Atlanta Criteria between the naldemedine group and the placebo group.
The Atlanta Criteria is the current gold standard for the diagnosis of AP attack, and it requires a minimum of two out three of the following features:
(i) Abdominal pain typical for acute pancreatitis featuring acute onset of a severe and persistent epigastric pain radiating to the back (ii) Serum amylase levels > three times greater than the normal upper limit (iii) Findings of pancreatic inflammation in contrast-enhanced computed tomography, magnetic resonance imaging or transabdominal ultrasonography.
Measured: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months
Secondary outcomes (9)
Pain intensity
Individual difference between subgroups in number and severity of pain attacks (without fulfilling AP criteria) assessed by pain diary and modified Brief Pain Inventory short form on visual analogue scale from 0-10 (0 is no pain and 10 is worst pain). For each attack, participants will be asked to fill in the pain attack diary and the modified Brief Pain Inventory short form once.
Measured: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months
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: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
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: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
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 a minimum of 6 months and a maximum of 12 months
Pancreatic volume
Difference in pancreatic volume measured in cubic centimeters cm^3 between subgroups, measured by MRI.
Measured: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Exocrine pancreatic function
Difference between subgroups in exocrine pancreatic function assessed by fecal-elastase (µg/g) test.
Measured: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Endocrine pancreatic function
Difference between subgroups in endocrine pancreatic function assessed by hemoglobinA1c (HbA1c) (mmol/mol) test.
Measured: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Quality of life (EORTC QLQ-C30)
Difference between subgroups in quality of life assessed by EORTC QLQ-C30 questionnaire. The questionnaire has been validated for assessment of quality of life in patients with chronic pancreatitis and is composed of single-item measures and multi-item scales with scores ranging from 0 to 100 after linear transformation of the raw score. A high score for a functional scale represents a high level of functioning, as does a high score for the global health status, while a high score for the symptom items represents a high level of symptomatology.
Measured: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Impression of change
Difference between subgroups in Patient Global Impression of Change. PGIC is a seven-point rating scale for self-report of a patient's experienced efficacy of treatment on their symptoms.
Measured: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start12 Jan 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
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 Pancreatitis, AcuteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 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, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Asbjørn Mohr Drewes, Aalborg University Hospital
- Investigators
- Asbjørn M. Drewes, Professor, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966559
- Sponsor's protocol ID
- PAMORA_RAP
- Other IDs
- 2021-000069-34, N-20210034
- Status last verified
- Mar 2024
- First submitted
- 8 Jul 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cook ME, Knoph CS, Davidsen L, Frokjaer JB, Bruun NH, Novovic S, Hadi A, Jorgensen MT, Mortensen MB, Schaffalitzky O, Nielsen LBJ, Berner-Hansen M, Drewes AM, Olesen SS. Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70178. doi: 10.1002/ueg2.70178.
PubMed 41553774Cook ME, Knoph CS, Fjelsted CA, Frokjaer JB, Bilgrau AE, Novovic S, Jorgensen MT, Mortensen MB, Nielsen LBJ, Hadi A, Berner-Hansen M, Rutkowski W, Vujasinovic M, Lohr M, Drewes AM, Olesen SS. Effects of a peripherally acting micro-opioid receptor antagonist for the prevention of recurrent acute pancreatitis: study protocol for an investigator-initiated, randomized, placebo-controlled, double-blind clinical trial (PAMORA-RAP trial). Trials. 2023 May 1;24(1):301. doi: 10.1186/s13063-023-07287-z.
PubMed 37127657
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04966559
- Acronym / sponsor ID
- PAMORA_RAP
- Conditions
- Pancreatitis, Acute
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Asbjørn Mohr DrewesUniversity, hospital or other
- Collaborators
- Odense University Hospital, Hvidovre University Hospital, University Hospital Bispebjerg and Frederiksberg, Karolinska University Hospital
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 19 Jul 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 a peripheral acting opioid antagonist (PAMORA) on the disease course of patients with recurrent acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating outpatients suffering from recurrent acute pancreatitis with a PAMORA (naldemedine) for 12 months.
Detailed description
In this study, the effects of a peripheral acting µ-opioid receptor antagonist (PAMORA) on disease recurrence and progression in patients with recurrent acute pancreatitis (RAP) will be investigated. Patients with RAP will be administered 0,2 mg naldemedine orally daily or matching placebo. This medication is defined as the investigational product. Naldemedine is approved by the European Medical Agency 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.
It is hypothesized that treatment with the PAMORA naldemedine will antagonize the harmful effects of opioids without reducing analgesia in patients with RAP and hence reduce disease severity and improve clinical outcomes. If successful, this study will for the first time document the effects of a targeted pharmacotherapy in RAP with the potential benefit of improved patient outcomes.
Study design
- Primary purpose
- Prevention
- 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 treatmentFilm-coated matched placebo-tablets consisting of: Core: Mannitol, USP/Ph. Eur./JP Croscarmellose Sodium, NF/Ph. Eur./JP Magnesium Stearate, NF/Ph. Eur./JP Coating: Opadry Yellow Purified Water, USP/EP |
| Naldemedine treatment | Active comparator | Drug: Naldemedine 0.2 MG Oral TabletFilm-coated matched active-tablets consisting of: Core: Naldemedine Tosylate (0,2 mg) Mannitol, USP/Ph. Eur./JP Croscarmellose Sodium, NF/Ph. Eur./JP Magnesium Stearate, NF/Ph. Eur./JP Coating: Opadry Yellow Purified Water, USP/EP |
Who may qualify
- Ages
- 18 to 74 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 or Swedish (depending on site)
- Male or female age between 18 and 74 years
- At least one attack of non-biliary AP (as defined by the revised Atlanta criteria) within the last 12 months and at least two attacks within 5 years
- Clinically stable at time of inclusion
Key exclusion criteria (9 listed)
- 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 eGFR below 45)
- Female participants that are lactating
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 handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days. | Drug | Placebo treatment |
| Naldemedine 0.2 MG Oral TabletActive drug/placebo is handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days. | Drug | Naldemedine treatment |
Primary outcome
Number of AP attacks verified by the Atlanta Criteria
Time frame: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months
The primary outcome is defined as time to (recurrent) AP attack(s) verified by the Atlanta Criteria between the naldemedine group and the placebo group. The Atlanta Criteria is the current gold standard for the diagnosis of AP attack, and it requires a minimum of two out three of the following features: (i) Abdominal pain typical for acute pancreatitis featuring acute onset of a severe and persistent epigastric pain radiating to the back (ii) Serum amylase levels > three times greater than the normal upper limit (iii) Findings of pancreatic inflammation in contrast-enhanced computed tomography, magnetic resonance imaging or transabdominal ultrasonography.
9 secondary outcomes
Pain intensity
Time frame: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months
Gut function (BSFS)
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Gut function (GSRS)
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Health resource utilization
Time frame: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months
Pancreatic volume
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Exocrine pancreatic function
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Endocrine pancreatic function
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Quality of life (EORTC QLQ-C30)
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Impression of change
Time frame: Day of randomization and at follow up visit after a minimum of 6 months and a maximum of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 41553774Cook ME, Knoph CS, Davidsen L, Frokjaer JB, Bruun NH, Novovic S, Hadi A, Jorgensen MT, Mortensen MB, Schaffalitzky O, Nielsen LBJ, Berner-Hansen M, Drewes AM, Olesen SS. Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70178. doi: 10.1002/ueg2.70178.
- Derived from this study: PubMed 37127657Cook ME, Knoph CS, Fjelsted CA, Frokjaer JB, Bilgrau AE, Novovic S, Jorgensen MT, Mortensen MB, Nielsen LBJ, Hadi A, Berner-Hansen M, Rutkowski W, Vujasinovic M, Lohr M, Drewes AM, Olesen SS. Effects of a peripherally acting micro-opioid receptor antagonist for the prevention of recurrent acute pancreatitis: study protocol for an investigator-initiated, randomized, placebo-controlled, double-blind clinical trial (PAMORA-RAP trial). Trials. 2023 May 1;24(1):301. doi: 10.1186/s13063-023-07287-z.
- 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 principal investigator
Aalborg University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naldemedine 0.2 MG Oral Tablet in people with Pancreatitis, Acute, run by Asbjørn Mohr Drewes at 5 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Sweden. 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?
Results are not available in the source record.
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 AP attacks verified by the Atlanta Criteria (time frame: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months). 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 NCT04966559, 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 Mar 2024.