Randomised trial of low dose, medium dose and high dose urodeoxycholic acid with placebo in primary sclerosing cholangitis
| ISRCTN | ISRCTN16531030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16531030 |
| Protocol serial number | N0503110014 |
| Sponsor | Department of Health (UK) |
| Funder | Newcastle upon Tyne Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Hudson
Scientific
Scientific
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
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 | Digestive System: Sclerosing cholangitis |
| Intervention | Trial of low dose, medium dose and high dose urodeoxycholic acid with placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | urodeoxycholic acid |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
