E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic fibromyalgia pain |
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E.1.1.1 | Medical condition in easily understood language |
Chronic fibromyalgia pain |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
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 |
The main objective is to assess whether Bediol (containing THC and CBD) co-treatment will reduce opioid side effects in chronic pain patients.
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E.2.2 | Secondary objectives of the trial |
A secondary objective will be that Bediol is superior to oxycodone in the relief of chronic fibromyalgia pain. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substantial Amendment as per Dec-2022 (protocol 18-Nov-2022): additional follow-up questionnaire |
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E.3 | Principal inclusion criteria |
Fibromyalgia patients with a pain score ≥ 5 (on a scale from 0 = no pain to 10 = most pain imaginable) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria (Wolfe F, Clauw DJ, Fitzcharles MA, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res 2010; 62: 600–10). These criteria include (i) a widespread pain index (WPI) ≥ 7 (on a scale from 0 to 19); (ii) and a symptom severity (SyS) score ≥ 5 (on a scale from 0 to 12) or a WPI of 3-6 and a SyS score ≥ 9.
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E.4 | Principal exclusion criteria |
(i) Unable to give written informed consent; (ii) presence of medical disease that may alter the pharmacokinetics of inhaled cannabinoids or oral oxycodone such as pulmonary or liver disease; (iii) allergy to study medication; (iv) prolonged use of strong opioids (> 3 months); (v) history of illicit drug abuse or alcohol abuse; (vi) (family) history of psychosis; (vii) pregnancy and/or lactation; (vii) the presence of pain syndromes other than fibromyalgia; (viii) age < 18 years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study outcome is the number of side effects observed during the course of treatment. To that end we will construct a composite side effects score. The score includes the following 10 symptoms dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, paranoia. The subjects will score all of these symptoms at the end of each day of treatment on paper. Each positive symptom will result in 1 point (max. score per day = 10) for the 42 days of treatment (= max. total score = 420). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary outcome is pain relief. Each day the patient will give an indication of the efficacy of pain treatment. There will be several questions asked (on paper): (1) How much pain did you experience on average over the last 24 h (score 0-10); (2) What was the maximum pain that you experienced over the last 24 h (score 0-10); (3) How satisfied are you with the treatment over the last 24 h (score 0-10); (4) How dissatisfied are you with your pain over the last 24 h (score 0-10); (5) How do you rate the treatment in relation to the side effects (score 0-10); Q1 and 2: score 0 = no pain, score 10 = the most severe pain imaginable; Q3-5: score 0 = not satisfied at all, score 10 = very satisfied with this treatment; At the end of the treatment period we will ask these same questions but then also for the complete treatment period. Upon follow-up we will continue asking Q1 and 2 on a weekly basis for 6 weeks.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |