Condition category
Digestive System
Date applied
11/07/2004
Date assigned
12/07/2004
Last edited
10/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pieter ter Borg

ORCID ID

Contact details

Albert Schweitzerplaats 25
Dordrecht
3318AT
Netherlands
+31 (0)786541111
pterborg@zonnet.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Primary biliary cirrhosis and primary sclerosing cholangitis

Intervention

Fluvoxamine treatment (150 mg/day) for a six-week period versus treatment with placebo. A double-blind placebo-controlled randomised trial.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluvoxamine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2001

Overall trial end date

01/06/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with primary biliary cirrhosis or primary sclerosing cholangitis and chronic significant fatigue.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

33

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2001

Recruitment end date

01/06/2002

Locations

Countries of recruitment

Netherlands

Trial participating centre

Albert Schweitzerplaats 25
Dordrecht
3318AT
Netherlands

Sponsor information

Organisation

Foundation for Liver Research (Stichting Lever Onderzoek) (The Netherlands)

Sponsor details

Erasmus Medical Centre
Dr. Molewaterplein 40
Rotterdam
3015GD
Netherlands
+31 (0)10 463 9222
h.vanbuuren@erasmusmc.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Gastrostart foundation (The Netherlands) (ref: EUR 4537)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15251034

Publication citations

  1. Results

    ter Borg PC, van Os E, van den Broek WW, Hansen BE, van Buuren HR, Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634]., BMC Gastroenterol, 2004, 4, 13, doi: 10.1186/1471-230X-4-13.

Additional files

Editorial Notes