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Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial.
ISRCTN ISRCTN88246634
DOI 10.1186/ISRCTN88246634
ClinicalTrials.gov identifier
EudraCT number
Public title Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial.
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis Not provided at time of registration
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Primary biliary cirrhosis and primary sclerosing cholangitis
Participants - inclusion criteria Patients with primary biliary cirrhosis or primary sclerosing cholangitis and chronic significant fatigue.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/10/2001
Anticipated end date 01/06/2002
Status of trial Completed
Patient information material
Target number of participants 33
Interventions Fluvoxamine treatment (150 mg/day) for a six-week period versus treatment with placebo. A double-blind placebo-controlled randomised trial.
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Gastrostart foundation (The Netherlands) (ref: EUR 4537)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15251034
Contact name Dr  Pieter  ter Borg
  Address Albert Schweitzerplaats 25
  City/town Dordrecht
  Zip/Postcode 3318AT
  Country Netherlands
  Tel +31 (0)786541111
  Fax +31 (0)786523569
  Email pterborg@zonnet.nl
Sponsor Foundation for Liver Research (Stichting Lever Onderzoek) (The Netherlands)
  Address Erasmus Medical Centre
Dr. Molewaterplein 40
  City/town Rotterdam
  Zip/Postcode 3015GD
  Country Netherlands
  Tel +31 (0)10 463 9222
  Email h.vanbuuren@erasmusmc.nl
Date applied 11/07/2004
Last edited 10/08/2007
Date ISRCTN assigned 12/07/2004
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