Clinical Trial Results:
Effects of a peripherally acting μ-opioid receptor antagonist on recurrent acute pancreatitis: An investigator-initiated, randomized, placebo-controlled, double-blind clinical trial
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Summary
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EudraCT number |
2021-000069-34 |
Trial protocol |
DK |
Global end of trial date |
03 Jun 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jul 2025
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First version publication date |
20 Jul 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PAMORA_2020_RAP
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04966559 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Mech-Sense, Aalborg University Hospital
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Sponsor organisation address |
Mølleparkvej 4, Aalborg, Denmark, 9320
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Public contact |
Mathias Ellgaard Cook, Mech-Sense, Aalborg University Hospital, +45 97663520, m.cook@rn.dk
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Scientific contact |
Mathias Ellgaard Cook, Mech-Sense, Aalborg University Hospital, +45 97663520, m.cook@rn.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Sep 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Jun 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jun 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
In outpatients with recurrent acute pancreatitis it will be investigated whether 12 months treatment with oral naldemedine will significantly reduce the number of pancreatitis attacks as compared to placebo.
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Protection of trial subjects |
The safety and well-being of all participants are prioritized throughout the trial in accordance with Good Clinical Practice (GCP) and applicable regulatory requirements. Adverse events and safety concerns are continuously monitored, assessed, and reported as required to relevant authorities and ethics committees. Appropriate follow-up is conducted to ensure resolution or stabilization of any safety issues. All trial procedures are designed to minimize risk and ensure participant protection at every stage.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 74
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Worldwide total number of subjects |
74
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EEA total number of subjects |
74
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
65
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
Inclusion started at the Aalborg site 12-01-2022, Bispebjerg 19-04-2022, Hvidovre 27-04-2022 and Odense 23-06-2022. Recruitment ended on all sites October 30, 2023. | ||||||||||||||||||
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Pre-assignment
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Screening details |
Patient with a history of recurrent acute pancreatitis were approach either after acute admissions or from outpatient clinics. In total 88 patients were assessed for eligibility and 14 were excluded since they did not meeting the exact inclusion criteria (7), or did not want to participate (7). | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||
Blinding implementation details |
The randomization and intervention allocation procedures were handled by pharmacists at Aalborg University Hospital, who were not affiliated with the trial. Participants were randomized to active treatment (tablet naldemedine 0.2 mg) or placebo in a 1:1 ratio using the web-based tool provided by www.sealedenvelope.com with random block size.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Active, Naldemedine | ||||||||||||||||||
Arm description |
Active, Naldemedine | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Naldemedine 0.2mg Film-coated Tablet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
0.2mg per day.
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Placebo | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
otherwise identical to the IMP
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Otherwise identical to the IMP
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Active, Naldemedine
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Reporting group description |
Active, Naldemedine | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||
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End point title |
Individual difference in number of AP attacks verified by the Atlanta criteria between the naldemedine group and the placebo group during the 12-month treatment period | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
After 12 months
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Statistical analysis title |
Primary outcome | |||||||||
Statistical analysis description |
The Anderson-Gill method for recurrent event analysis
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Comparison groups |
Active, Naldemedine v Placebo
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Number of subjects included in analysis |
74
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.054 | |||||||||
Method |
Anderson-Gill | |||||||||
Parameter type |
Hazard ratio (HR) | |||||||||
Point estimate |
0.54
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.29 | |||||||||
upper limit |
1.01 | |||||||||
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End point title |
Difference in number and severity (assessed by questionnaires) of pain attacks (without fulfilling AP criteria) between subgroups during the 12-month treatment period | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 12 months
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| No statistical analyses for this end point | ||||||||||
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End point title |
Difference in gut function assessed with the Bristol Stool Form Scale between subgroups from baseline to 12 months follow-up | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 12 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Difference in exocrine pancreas function between subgroups, assessed by new-onset EPI, from baseline to 12 months follow-up | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 12 months
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| No statistical analyses for this end point | ||||||||||
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End point title |
Difference in gut function assessed with the Gastrointestinal Symptom Rating Scale between subgroups from baseline to 12 months follow-up | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 12 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Difference in endocrine pancreas function between subgroups, assessed by new-onset diabetes, from baseline to 12 months follow-up | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 12 months
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| No statistical analyses for this end point | ||||||||||
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End point title |
Difference between subgroups in quality of life, assessed by questionnaires, from baseline to 12 months follow-up | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 12 months
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
After 12 months
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Adverse event reporting additional description |
Monthly phonecalls and visits at study end.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
None | ||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Active, Naldemedine
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Reporting group description |
Active, Naldemedine | ||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
