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The SPIROCAN


- candidate number25312
- NTR NumberNTR6091
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2016
- Secondary IDsp15.316 LUMC
- Public TitleThe SPIROCAN
- Scientific TitleThe effects of inhaled delta‐9‐tetrahydrocannabinol (THC) and cannabidiol (CBD) on pain relief and subjective effects in fibromyalgia patients - A placebo controlled pharmacokinetic‐pharmacodynamic study
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedFibromyalgia
- Inclusion criteriaFemale 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.
- Exclusion criteria(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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate
- Target number of participants20
- InterventionsPatients will inhale Bedrocan©, Bedrolite© and Bediol© (Bedrocan BV, Veendam, The Netherlands) on four separate treatment days.
- Primary outcomePK data, spontaneous and experimental pain relief
- Secondary outcomeMental state using Bowdle and Bond & Lader questionnaires.
- TimepointsPatients will visit the clinic 4 times. Each visit they will inhale either Bedrocan©, Bedrolite©,Bediol© or placebo.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Niesters
- CONTACT for SCIENTIFIC QUERIESDr. M. Niesters
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryPatients 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)
- Main changes (audit trail)
- RECORD19-sep-2016 - 11-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl