E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with persistent postsurgical abdominal pain |
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E.1.1.1 | Medical condition in easily understood language |
Patients with persistent abdominal pain after surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060932 |
E.1.2 | Term | Postoperative adhesion |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000081 |
E.1.2 | Term | Abdominal pain |
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 analgesic efficacy of a stable dose Namisol® in patients suffering from persistent postsurgical abdominal pain. |
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E.2.2 | Secondary objectives of the trial |
- To investigate the effect of a stable dose Namisol® on central nervous system processing (measured by EEG, QST, DNIC) in patients suffering from persistent postsurgical abdominal pain.
- To evaluate the effect of a stable dose Namisol® on anxiety and depression (HADS), general health (SF-36), pain catastrophizing (PCS), global impression of change (PGIC), pain related anxiety (PASS) in patients suffering from persistent postsurgical abdominal pain.
- To evaluate the effect of a stable dose Namisol® on safety and tolerability (adverse events) in patients suffering from persistent postsurgical abdominal pain.
- To evaluate the effect of a stable dose Namisol® on pharmacokinetics (PK) and pharmacodynamics (PD) in patients suffering from persistent postsurgical abdominal pain.
- To evaluate the effect of a stable dose Namisol® on body weight and the amount of supplementary feeding intake in patients suffering from persistent postsurgical abdominal pain.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Aged 18 years or older
•Postsurgical pain
•Pain duration exceeding 3 months, and average NRS≥3
•Stable doses intake of analgesics for the past 2 months
•The patient has been informed about the study, understood the information and signed the informed consent form
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E.4 | Principal exclusion criteria |
•Patient is diagnosed with irritated bowel syndrome (IBS) or chronic pancreatitis
•Patient has an indication for a pain treatment other then medication
•Patient took cannabinoids on a regular basisin past 3 years
•Patient does not feel a pinprick test in the lower extremities
•Patient has a body mass index (BMI) above 33,0 kg/m2
•Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
•Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
•Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
•Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
•Patient has an actual moderate to severe renal impairment
•Patient has an actual moderate to severe hepatic impairment
•Patient has a presence or history of major psychiatric illness
•Patient has experienced an epileptic seizure in the past
•Patient demonstrates clinically significant laboratory abnormalities
•Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
•Patient an active hepatitis B, hepatitis C or HIV infection
•Patient has a history of sensitivity / idiosyncrasy to THC
•Patient has a known or suspected lactose intolerance
•Female patient is pregnant or breastfeeding
•Patient intends to conceive a child during the course of the study
•Patient participates in another investigational drug study
•Patient has a clinical significant exacerbation in illness
•Patient is unwilling or unable to comply with the lifestyle guidelines |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Pain intensity (diary)
o VAS average pain |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0 (baseline) versus day 52 |
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E.5.2 | Secondary end point(s) |
• Pain intensity (diary)
o VAS minimal pain
o VAS maximal pain
• EEG
o ERPs to noxious electrical stimuli
o ERPs to auditory stimuli (oddball)
o FFT spontaneous EEG
• QST (visceral screenings protocol)
o Pressure pain thresholds
o Electric pain thresholds
o Electric wind-up response
o DNIC
• Questionnaires
o Izbicki
o PGIC
o PCS
o VASBond & Lader
o VASBowdle
o SF-36
o HADS
o PASS
• Pharmacodynamics
o Body Sway
• Functional
o Body weight
o Supplementary feeding
• Safety
o Laboratory
o ECG
o HF / BP
o Adverse events
• Pharmacokinetics
o THC, 11-OH-THC and THC-COOH concentrations |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Repeatedly, from day 0 (baseline) versus day 52 |
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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 | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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 | Yes |
E.8.2.3 | Other | No |
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 | No |
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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last visit of the last subject |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |