Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
10/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes