ID
Bron
Aandoening
Fibromyalgia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
PK data, spontaneous and experimental pain relief
Achtergrond van het onderzoek
Patients will be randomized to receive any of these 4 treatments: Bedrocan©, Bedrolite©,Bediol© or placebo. All four treatments will be administered by vaporizing using the Volcano Medic vaporizer. During and after inhalation multiple blood samples will be collected, to measure the pharmacokinetic effect. Electric and pressure pain tests will be used to measure the analgesic effect. Side-effects will be evaluated by two questionnaires (Bowdel and Bond&Lader)
Onderzoeksopzet
Patients will visit the clinic 4 times. Each visit they will inhale either Bedrocan©, Bedrolite©,Bediol© or placebo.
Onderzoeksproduct en/of interventie
Patients will inhale Bedrocan©, Bedrolite© and Bediol© (Bedrocan BV, Veendam, The Netherlands) on four separate treatment days.
Publiek
M. Niesters
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
071-5262301
m.niesters@lumc.nl
Wetenschappelijk
M. Niesters
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
071-5262301
m.niesters@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Female fibromyalgia patients will be included if they have a pain score ≥ 5 for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(i) Unable to give written informed consent; (ii) presence of medical disease that may alter PKPD of cannabinoids such as pulmonary, renal, liver, cardiac, gastro‐intestinal, vascular disease; (iii) allergy to study medication; (iv) use of strong opioids; (v) use of benzodiazepines; (vi) history of illicit drug abuse (incl. cannabisrelated products) or alcohol abuse; (vii) (family) history of psychosis; (viii) epilepsy; (ix) raised intracranial pressure;(x) pregnancy and/or lactation; (xi) the presence of pain syndromes other than fibromyalgia; (xii) age < 18 years.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5903 |
| NTR-old | NTR6091 |
| Ander register | LUMC : p15.316 |