Randomised double-blind placebo controlled trial of treatment with pioglitazone in non-alcoholic steatohepatitis
| ISRCTN | ISRCTN10319160 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10319160 |
| Protocol serial number | N0192119052 |
| Sponsor | Department of Health (UK) |
| Funder | Queens Medical Centre University Hospital NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 10/03/2011
- 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 GP Aithal
Scientific
Scientific
D Floor
South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 0115 924 9924 (ext 65747) |
|---|---|
| guru.aithal@mail.qmcuh-tr.trent.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Does pioglitazone improve necro-inflammation associated with non-alcoholic steatohepatitis (NASH)? |
| Ethics approval(s) | Added 27/03/08: Approved by Nottingham Joint Ethics Committee, ref GM050201, 25/11/2002. |
| Health condition(s) or problem(s) studied | Digestive System: Liver |
| Intervention | Pioglitazone vs placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | pioglitazone |
| Primary outcome measure(s) |
Necro-inflammation and fibrosis score on liver biopsy. |
| Key secondary outcome measure(s) |
1. Liver enzymes |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 75 |
| Key inclusion criteria | Added 27/03/08: 1. Age 18-70 years 2. Histological evidence of NASH |
| Key exclusion criteria | Added 27/03/08: 1. Alcohol consumption >21units in males and >14 units in females 2. Diabetes Mellitus 3. Consumption of drugs that cause fatty liver 4. Other liver diseases (clinical or on liver biopsy) |
| Date of first enrolment | 25/11/2002 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
D Floor
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
