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van CCT (UK)


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The FCAT


- candidate number25309
- NTR NumberNTR6090
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2016
- Secondary IDsP15.361 LUMC
- Public TitleThe FCAT
- Scientific TitleA randomized, double blind, placebo-controlled study on the effect of 3 months treatment with the analgesic tapentadol on conditioned pain modulation (CPM) and pain relief in patients with chronic pain from fibromyalgia
- ACRONYMFCAT (Fibromyalgia, CPM, Analgesia, Tapentadol)
- hypothesis1. Tapentadol produces effective pain relief
2. Tapentadol treatment improves/enlarges CPM resonses
3. Tapentadol treatment improves/reduces temporal summation responses
4. Tapentadol treatment improves/reduces offset analgesia responses
5. Tapentadol is most efficacious in patients with initial defects in CPM and/or in patients that have a neuropathic pain component
- Healt Condition(s) or Problem(s) studiedFibromyalgia
- Inclusion criteriaAmerican Society of Anesthesiologists class 1 and 2 patients, 18 75 years; BMI < 40 kg/m2.
Patients need to have a pain score ≥ 5 (on a scale of 0-10) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria. Patients need to have a absent/inactive CPM response.
- Exclusion criteriaUnable to give written informed consent; medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) history of illicit drug abuse or alcohol abuse; (v) history of psychosis; (vi) epilepsy; (vii) pregnancy and/or lactation; (viii) strong opioids and benzodiazepine use.
Patients are not allowed to continue co-analgesics that target CPM.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate
- Target number of participants40
- InterventionsPatients will be treated with a placebo or Tapentadol for 3 months.
- Primary outcome- Conditioned Pain Modulation (CPM)
- Temporal summation (TS)
- Offset Analgesia (OA)
- Pain relief
- Secondary outcome- Pain Detect questionnaire
- The Big Five Inventory
- Profile Of Mood States
- Neuropathic Pain Symptoms Inventory Questionnaire
- Hospital Anxiety and Depression Scale (HADS)
- C-fiber density in the cornea
- TimepointsPatients will be treated for 3 months. Once a month the will visit the hospital to test CPM, TS and OA until one month after the medication is stopped.
- Trial web site
- statusopen: patient inclusion
- 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 phenotyped in term of endogenous pain modulation (CPM, OA), temporal summation, C-fiber density in the cornea, neuropathic pain symptoms and mood-related symptoms.
In case of an absent CPM a patients is included and randomized to receive either placebo or Tapentadol. Patients are treated for 3 months, they will visit the clinic monthly to preform tests (CPM, OA, TS, questionnaires), until one month after the medication is stopped.
- Main changes (audit trail)
- RECORD19-sep-2016 - 11-nov-2016


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