Contact information
Type
Scientific
Primary contact
Dr GP Aithal
ORCID ID
Contact details
D Floor
South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 0115 924 9924 (ext 65747)
guru.aithal@mail.qmcuh-tr.trent.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192119052
Study information
Scientific title
Acronym
Study hypothesis
Does pioglitazone improve necro-inflammation associated with non-alcoholic steatohepatitis (NASH)?
Ethics approval
Added 27/03/08:
Approved by Nottingham Joint Ethics Committee, ref GM050201, 25/11/2002.
Study design
Randomised double-blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Digestive System: Liver
Intervention
Pioglitazone vs placebo
Intervention type
Drug
Phase
Not Specified
Drug names
pioglitazone
Primary outcome measures
Necro-inflammation and fibrosis score on liver biopsy.
Secondary outcome measures
1. Liver enzymes
2. Clinical and biochemical parameters of metabolic syndrome
Overall trial start date
25/11/2002
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Added 27/03/08:
1. Age 18-70 years
2. Histological evidence of NASH
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total number of subjects = 124. Number as of 28/03/07: 75
Participant 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)
Recruitment start date
25/11/2002
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
D Floor
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queens Medical Centre University Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18718471
Publication citations
-
Results
Aithal GP, Thomas JA, Kaye PV, Lawson A, Ryder SD, Spendlove I, Austin AS, Freeman JG, Morgan L, Webber J, Randomized, placebo-controlled trial of pioglitazone in nondiabetic subjects with nonalcoholic steatohepatitis., Gastroenterology, 2008, 135, 4, 1176-1184, doi: 10.1053/j.gastro.2008.06.047.