E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with abdominal pain as a result of chronic pancreatitis |
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E.1.1.1 | Medical condition in easily understood language |
Chronic inflammation of the pancreas |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033649 |
E.1.2 | Term | Pancreatitis chronic |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009093 |
E.1.2 | Term | Chronic pancreatitis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of Namisol® after a single dose of THC on the experienced pain intensity (measured by the VASpain) in patients with chronic pancreatitis. |
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E.2.2 | Secondary objectives of the trial |
- To investigate the efficacy of Namisol® after a single dose of THC on experimental pain mechanisms (measured by EEG, QST, and DNIC) in patients with chronic pancreatitis.
- To evaluate the safety and tolerability of Namisol® after a single dose of THC in patients with chronic pancreatitis.
- To evaluate the pharmacokinetics (PK) of Namisol® after a single dose of THC in patients with chronic pancreatitis.
- To evaluate (undesirable) pharmacodynamic (PD) effects of Namisol® after a single dose of THC in patients with chronic pancreatitis.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is 18 years or older on the day the informed consent form will be signed.
2. Patient is male.
3. Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
4. Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (intermittent or persistent pain on a daily basis in at least 3 months), and must consider their pain as severe enough for medical treatment (average NRS ≥ 3).
5. Patient in de opioid subgroup takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the investigator.
6. Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.
7. Patient is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
8. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
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E.4 | Principal exclusion criteria |
1. Patient did not took any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
2. Patient is insulin depended for more than 5 years on the day of screening.
3. Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
4. Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
BMI (kg/m²) = weight (kg) / (height * height) (m2)
5. Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
6. Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
7. Patient uses any kind of concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals or proton-pump inhibitors).
8. Patient takes drip-feed.
9. Patient takes amitriptyline on a daily base and is unable/unwilling to refrain from amitriptyline from 24 hours before each study day.
10. Patient demonstrates deviating ECG parameters at screening, e.g. heart rate >100 bpm, QRS duration >120 msec, QTc interval >450 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
11. Patient is previously diagnosed with moderate to severe renal impairment, e.g. creatinine values > 2x ULN and/or a significant change of their normal values.
12. Patient is previously diagnosed with moderate to severe hepatic failure or show significant clinical abnormalities in biochemistry blood sample.
13. Patient has a presence or history of major psychiatric illness as judged by investigator, e.g. major depression, schizophrenia.
14. Patient demonstrates clinically significant laboratory 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.
15. Patient has a history of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or to any other related drug used in the past.
16. Patient shows a positive alcohol breath test at screening or admission and/or is unable/unwilling to refrain from alcohol use from 48 hours before each study day until the last blood sample has been drawn.
17. Patient demonstrates a positive urine screen at screening visit for THC, cocaine, MDMA, and amphetamines.
18. Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test.
19. Patient is unwilling or unable to comply with the lifestyle guidelines.
20. Patients intends to father a child during the course of the study.
21. Patient participates in another investigational drug study within 90 days prior to the first dose and/or participates in more than 2 clinical trials in the last year.
22. Patient has a clinical significant exacerbation in illness within two weeks of participating in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain intensity:
- VAS pain rest
- VAS pain movement
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Repeatedly; baseline until 6 hours after single dose administration |
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E.5.2 | Secondary end point(s) |
EEG; ERPs to noxious stimuli and spontaneous EEG
QST; mechanical and electrical pain thresholds
Body Sway; static 2 dimensional body sway |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Repeatedly; baseline until 6 hours after administration |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |