Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial.
| ISRCTN | ISRCTN88246634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88246634 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/07/2004
- Registration date
- 12/07/2004
- Last edited
- 10/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pieter ter Borg
Scientific
Scientific
Albert Schweitzerplaats 25
Dordrecht
3318AT
Netherlands
| Phone | +31 (0)786541111 |
|---|---|
| pterborg@zonnet.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluvoxamine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2001 |
| Completion date | 01/06/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 33 |
| Key inclusion criteria | Patients with primary biliary cirrhosis or primary sclerosing cholangitis and chronic significant fatigue. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 01/06/2002 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Albert Schweitzerplaats 25
Dordrecht
3318AT
Netherlands
3318AT
Netherlands
Sponsor information
Foundation for Liver Research (Stichting Lever Onderzoek) (The Netherlands)
Research organisation
Research organisation
Erasmus Medical Centre
Dr. Molewaterplein 40
Rotterdam
3015GD
Netherlands
| Phone | +31 (0)10 463 9222 |
|---|---|
| h.vanbuuren@erasmusmc.nl | |
"ROR" |
https://ror.org/04hzejq44 |
Funders
Funder type
Research organisation
Gastrostart foundation (The Netherlands) (ref: EUR 4537)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 13/07/2004 | Yes | No |
