Status:
COMPLETED
Neuromodulation in Patients With Painful Chronic Pancreatitis
Lead Sponsor:
Jens Brøndum Frøkjær
Collaborating Sponsors:
ElectroCore INC
Conditions:
Painful Chronic Pancreatitis
Visceral Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to explore if a novel vagal neuromodulation approach provides analgesic benefit through central mechanisms in patients with chronic pancreatitis
Detailed Description
This study is a randomized, double blind, sham-controlled, cross-over, controlled investigation. The overall objective of the study is to conduct a study of vagal tone and the sensory system (brain ac...
Eligibility Criteria
Inclusion
- Patients from the ages of 18 with a diagnosis of CP diagnosed using the Mayo Clinic diagnostic criteria.
- The participants must be able to read and understand Danish.
- The patients must suffer from chronic abdominal pain characteristic for CP, meet the criteria for chronic pain (pain ≥ 3 days per week in at least 3 months) and must consider their pain as insufficiently treated with their usual analgesic treatment.
- Personally, signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial as well as signing the following document: "Informeret samtykke om opbevaring af biologisk material i biobank til fremtidig forskning".
- Personally, signed and dated the Power of attorney document (Fuldmagtserklæring) indicating that the patient has accepted that the Danish Medical Agency Sundhedsstyrelsen/Lægemiddelstyrelen) have access to the medical records.
- Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Exclusion
- Patients with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- Alcohol dependence (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
- Illegal drug dependencies.
- Participating in another study where investigational drug is used.
- Patients must not suffer from painful conditions other than CP that make them unable to distinguish the pain associated with CP from chronic pain of other origin.
- Cardiovascular diseases
- Low blood pressure \< 100/60
- Not able to understand or follow the instructions.
- Any condition with elevated intracranial pressure.
- Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during the course of the study. A pregnancy test will be conducted at baseline and after 8 weeks to ensure that female patients are not pregnant during the study medication period. The investigator will have to urge that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study medication period. The following methods are considered as safe contraception methods:
- The combined oral contraceptive pill
- Intra uterine device
- Gestagen injection
- Subdermal implantation
- Hormone vaginal ring
- Transdermal plaster
- Contraindications for MRI: Such as metallic Foreign Body in the Eye, "Triggerfish" Contact Lens, Gastric Reflux Device, Insulin Pumps, Permanent pacemaker, Temporary external transvenous pacing leads, Other implantable metallic components which is considered unsafe by the medical doctor.
- Previous surgery on vagus nerve.
- Known neuropathy.
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03357029
Start Date
January 11 2018
End Date
April 30 2019
Last Update
February 17 2022
Active Locations (1)
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1
Mech-Sense, Department of Radiology
Aalborg, Denmark, 9000