The Effect of Bezafibrate on Cholestatic Itch (NCT02701166) | Clinical Trial Compass
UnknownPhase 3
The Effect of Bezafibrate on Cholestatic Itch
Netherlands84 participantsStarted 2016-02
Plain-language summary
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
* itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.
Exclusion Criteria:
* Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.
rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);
* Pregnancy, women of childbearing potential not using contraception, breast feeding;
* Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
* Use of opiates;
* Renal insufficiency (creatinine clearanc…
What they're measuring
1
Proportion of patients with a reduction in itch intensity of 50% or more
Timeframe: 3 weeks
Trial details
NCT IDNCT02701166
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)