Randomised double-blind placebo controlled trial of treatment with pioglitazone in non-alcoholic steatohepatitis

ISRCTN ISRCTN10319160
DOI https://doi.org/10.1186/ISRCTN10319160
Secondary identifying numbers N0192119052
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

D Floor
South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone +44 0115 924 9924 (ext 65747)
Email guru.aithal@mail.qmcuh-tr.trent.nhs.uk

Study information

Study designRandomised double-blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesDoes 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) studiedDigestive System: Liver
InterventionPioglitazone vs placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)pioglitazone
Primary outcome measureNecro-inflammation and fibrosis score on liver biopsy.
Secondary outcome measures1. Liver enzymes
2. Clinical and biochemical parameters of metabolic syndrome
Overall study start date25/11/2002
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participantsTotal number of subjects = 124. Number as of 28/03/07: 75
Key inclusion criteriaAdded 27/03/08:
1. Age 18-70 years
2. Histological evidence of NASH
Key exclusion criteriaAdded 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 enrolment25/11/2002
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

D Floor
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Queens Medical Centre University Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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