E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain in patients with fibromylagia |
Smerter hos patienter med fibromyalgi |
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E.1.1.1 | Medical condition in easily understood language |
Pain in patients with fibromylagia |
Smerter hos patienter med fibromyalgi |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
E.1.2 | System Organ Class | 100000004867 |
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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 |
Main objective is to investigate effect and mechanism of low dose naltrexone in the treatment of pain in patients with fibromyalgia |
Formålet er at undersøge effekt og mekanisme af lav dosis naltrexon til behandling af smerter hos patienter med fibromyalgi |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives:
- fatigue
- sleep problems
- activity level
- side effect of low dose naltrexone
- pain intensity in relation to experimental pain testing |
Sekundære formål:
- træthedsfølelse
- søvnproblemer
- aktivitetsniveau
- bivirkninger til lav dosis naltrexon
- smerteintenstitet i henhold til eksperimentelle smertemålinger |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- > 18 years
- Fibromyalgi
- Patient in one of the involved pain centre in the study
- No inflammatory rheumatic pain condition
- Women - treatment with contrceptiva if not menopausal |
- > 18år
- Udbredte smerter af typen fibromyalgi
- Indskrevet som patient på en af de respektive Smerteklinikker
- Inflammatorisk reumatisk lidelse skal være udelukket
- Kvinder skal være i behandling med kontraceptiva , hvis ikke menopausal
|
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E.4 | Principal exclusion criteria |
- Cancer
- Treatment with opioids (other stable analgesic treatment 14 days before study start is allowed
- No change in stable analgesic treatment (p.n. paracetamol is allowed)
- Pregnant/breatfeeding
- Don´t speak danish
- Allergic to ingredient
|
- Cancer
- I behandling med opioider (anden analgetika i stabil dosis 14 dage før opstart er tilladt)
- Ingen ændring i fast analgetika behandling (p.n. paracetamol må anvendes, skal dog registreres) [NSAID?]
- Gravide/ammende
- Behersker ikke det danske sprog
- Allergi overfor indholdsstof
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain intensity
Functionality |
Smerteintensitet
Funktionscores |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of trial |
Efter afslutning af studie |
|
E.5.2 | Secondary end point(s) |
- fatigue
- sleep problems
- activity level
- side effect of low dose naltrexone
- pain intensity in relation to experimental pain testing |
- træthedsfølelse
- søvnproblemer
- aktivitetsniveau
- bivirkninger til lav dosis naltrexon
- smerteintenstitet i henhold til eksperimentelle smertemålinger |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of trial |
Efter afslutning af studie |
|
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |