Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial.
| ISRCTN | ISRCTN88246634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88246634 |
| Protocol serial number | N/A |
| Sponsor | Foundation for Liver Research (Stichting Lever Onderzoek) (The Netherlands) |
| Funder | Gastrostart foundation (The Netherlands) (ref: EUR 4537) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluvoxamine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
